150 Gxp Jobs

As the Strategic and hands-on IT leader responsible for managing multi-site GxP-compliant IT operations and plant infrastructure in a regulated pharmaceutical environment, your role will be pivotal in ensuring uptime, compliance, and driving impactful technology-led business enablement. You will act as the Single Point of Contact (SPOC) for IT for site leadership, maintaining real-time audit readiness, enforcing regulatory-compliant practices, and collaborating with central SAP teams to align plant needs. With 9-14 years of experience in Pharma Plant IT Operations and audit exposure, along with a qualification in B.E. / B.Tech / BCA / BCS or an equivalent qualification, you will be expected to fulfill the following responsibilities: GxP IT Operations & Compliance: - Ensure 100% uptime of GxP-critical systems and infrastructure. - Maintain real-time audit readiness, manage SOP adherence, QMS notifications, CAPA closure, and periodic reviews. - Enforce regulatory-compliant practices for user access control, data integrity, and electronic records. - Collaborate with central SAP teams to align plant needs. IT Infrastructure & Security Management: - Oversee standardization, qualification, AMC, retirement, and reusability of IT assets. - Implement robust IT security controls, patch management, and cybersecurity governance. - Identify and eliminate CSV bottlenecks affecting manufacturing continuity. Audit & Regulatory Readiness: - Act as audit-facing SPOC for IT during internal and external audits. - Guide Site IT Leads to ensure readiness and compliance. - Lead pre-audit checks, documentation reviews, and post-audit CAPA implementation. - Ensure full alignment of IT practices with regulatory guidelines. Project Delivery & Solution Implementation: - Lead IT solution implementation at plant level. - Ensure IT assets and integrations are fully compliant with GxP requirements. - Drive digital transformation and automation initiatives. Team Leadership & Stakeholder Engagement: - Lead, coach, and upskill a 25+ member IT team. - Collaborate with Quality, Manufacturing, Engineering, and Projects teams. - Align IT strategy with plant KPIs. IT Governance & AIOps: - Implement AIOps and predictive monitoring for system reliability. - Define and track IT SLAs, KPIs, and compliance scorecards. - Drive innovation while ensuring adherence to IT Security standards. Value Addition: - Proven success in business continuity and audit compliance through IT solutions. - Spearheaded SAP-integrated projects and AIOps implementation. - Delivered cross-site standardization of IT operations. Desired Skills: - Deep knowledge of Pharma IT Compliance, plant automation systems, and IT infrastructure lifecycle. - Strong leadership, audit-facing, communication, and stakeholder management skills. - SAP certification & relevant IT certifications preferred. - Technical knowledge of SAP systems and IT infrastructure components. - Experience in SAP HANA, SAP Fiori, or similar technology is a plus. - Strong problem-solving, analytical, and troubleshooting skills. - Project management experience with familiarity in Agile and Waterfall methodologies. - Familiarity with security frameworks in SAP and IT infrastructure management. - Strong understanding of cybersecurity principles in plant IT environments. Your role will require a strategic mindset focused on operational efficiency and business alignment, along with the ability to lead a multidisciplinary team effectively and ensure compliance with regulatory and InfoSec standards.,

Handle market complaints received from across the globe. You will be responsible for reviewing the investigation reports received from the Novartis sites and Contract Manufacturing Organizations. You will collaborate with external Supply organization, Novartis sites, Country pharma organizations for continuous improvement. As a Specialist - Product Complaints - QOP based in Hyderabad, your key responsibilities will include performing day-to-day activities of processing market complaints assigned as per the relevant SOPs, business matrix, and SLA timelines. You will assist in data collection and reporting of KPIs, participate in continuous improvement initiatives, manage ad-hoc projects, and proactively report all deviations through timely escalations. Your role will also involve implementing continuous process improvement projects to enhance quality & productivity, ensuring that the service dashboard, order management framework, and time sheet are always kept updated. You will receive training on relevant procedures before taking up any GxP activities and report deliverable status while continuously acquiring process knowledge. The essential requirements for this role include having 5-8 years of relevant experience in Quality Operations, a thorough understanding of Quality Management Systems, and the ability to review market complaints investigation reports. You should have a basic understanding of product manufacturing, Pharma products and lifecycle events, Trackwise, performance KPIs, MS Excel, and awareness of GXP. Strong communication skills are essential, with fluency in verbal and written English; knowledge of other languages is an added advantage. A graduate or post-graduate degree in Pharmacy would be a desirable requirement for this position. Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities served. If you are looking to be part of a mission to reimagine medicine and improve lives, consider joining Novartis. To learn more about the benefits and rewards offered at Novartis, please refer to the Novartis Life Handbook. If this role does not align with your current experience or career goals, you can stay connected and learn about other career opportunities within Novartis by joining the Novartis Network. Novartis values the contribution of its associates in driving the company towards becoming the most valued and trusted medicines company in the world.,

PolyPeptide is on a transformative growth journey expanding globally, investing in new technologies, and increasing our production capacity through major site expansions and strategic projects, As part of this, we are launching a global SAP S/4HANA implementation to modernize and harmonize how we work across sites, systems, and teams This is a greenfield initiative and a truly unique opportunity to join from the very beginning and help build the ERP function that will support PolyPeptides operations for years to come, As the Head of ERP, youll take the lead in shaping and delivering this enterprise-wide ERP foundation Youll be a key player in driving digital transformation across the organization not just through implementation, but also by establishing a future-proof architecture, building internal capabilities, and creating a scalable, compliant SAP landscape, About Us PolyPeptide Group AG and its consolidated subsidiaries (?PolyPeptide?) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptideand oligonucleotide-based active pharmaceutical ingredients By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1 Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U S and India PolyPeptides shares (SIX: PPGN) are listed on SIX Swiss Exchange, Our Values Trust: We build and maintain trust in all our relationships both with each other and with our customers We support each other and work as a team, Innovation: We are curious and driven by finding smart solutions to the challenges we face, Excellence: We always strive to deliver high quality and adapt to meet the needs of our customers, About The Role As the Head of ERP, you will be responsible for the strategic and operational management of our SAP S/4HANA landscape Your primary focus will be to ensure that our ERP systems effectively support all core functions of a regulated CDMO from GMP-compliant manufacturing and quality control to finance, supply chain, and client project tracking, Youll lead a cross-functional team and work closely with internal stakeholders and external partners to design, implement, and evolve robust, scalable, and compliant SAP solutions Youll also play a key role in establishing our future SAP Customer Center of Excellence (CCOE), helping us build a stable, secure, and innovation-ready ERP backbone for the years to come, Key Responsibilities Define and execute the SAP ERP roadmap aligned with business growth, GMP compliance, and digital quality standards, Lead the delivery of SAP solutions supporting CDMO-specific processes such as batch tracking, client project management, and regulatory reporting, Oversee SAP-related projects, upgrades, and enhancements ensuring compliance with GxP and client-specific requirements, Serve as the primary point of contact for ERP across internal functions and client-facing teams, Manage a team of SAP functional and technical experts, including consultants and validation specialists, Evaluate and implement SAP innovations ( e-g , SAP QM, ATTP) to enhance efficiency and compliance, Ensure system availability, performance, and security for both GMP and non-GMP operations, Maintain ERP compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and client-specific agreements, Manage vendor relationships, including SAP service providers, system integrators, and external auditors, Collaborate closely with QA, Compliance, and Validation teams to enforce change control and audit readiness Your Profile Were looking for an experienced ERP leader who can combine technical insight, regulatory awareness, and business understanding: A Bachelors or Masters degree in Life Sciences, IT, Engineering or related field, 7+ years of experience with SAP ERP delivery, including at least 3 years in a leadership role, Experience from a regulated manufacturing or CDMO environment, Understanding of GxP systems, computerized system validation (CSV), and audit requirements, Familiarity with client project management, batch traceability, and supply chain processes, Strong leadership, stakeholder management, and communication skills, Proficient in English, both speaking and writing, Certifications ( e-g PMP, ITIL, SAP) are a plus, You are an inspiring and proactive leader who takes clear ownership, drives improvement, and thrives in complex cross-functional settings Youre passionate about digital transformation and committed to delivering quality and value together with your team, FIND THIS INTERESTINGAPPLY NOW! If you want to lead the implementation of a new, enterprise-wide SAP system and shape the future of our digital infrastructure at the forefront of pharmaceutical innovation, please send in your application right away The position will be open until August 17th, 2025, but we are applying ongoing selection so do not hesitate to send us your application, Our Global IS/IT team is primarily based in Malm?, but we also welcome applicants located near our other sites in Strasbourg, Braine, or Ambernath, provided you are within commuting distance, For more information, please contact Thomas Gerd Hansen at thomas gerdhansen@polypeptide or Dag Widell at dag widell@polypeptide Swedish applicants are welcome to contact the local union chairman for Akademikerf?reningen or Unionen at +46 040-36 62 00 for support, Show

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans Execution of validation plans and validation documents Qualifications we seek in you! Minimum Qualifications / Skills BE/B Tech Preferred Qualifications/ Skills Familiar with writing tests for Web-based software architectures Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent). Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus. Critical thinker and problem-solving skills Team player Good level in English Great interpersonal and communication skills Looking for Immediate to 45 days joiners.

Seeking a CSV Consultant to work on a variety of validation projects including manufacturing systems, lab systems, risk assessments, etc. Some of the work may be done remotely, some at client sites and others at one of our offices. Immediate start date Job Responsibilities: Responsible for the Computer System Validation processes of the company Maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11) Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply Minimum Requirements: Minimum degree requirement - Bachelor's degree with at least 10+ years of experience Must be willing to travel regionally and/or nationally throughout India Candidates must have excellent verbal communication and technical writing skills Experience in generation and execution of protocols and procedures related to different areas of qualification and validation Expertise in ISPE GAMP5, ICH Q8, ICH Q9, ICH Q10, 21 CFR Part 11, Computerized System Validation, Equipment Qualification, and Validation Change Control Working knowledge of protocol development for validation of complex computer systems (e.g., multiple GAMP classes of systems); ability to develop Installation, Operational, and Performance Qualification documents Experience in execution of system validation lifecycle deliverables Experience in project execution within at least one area of systems validation (e.g., laboratory equipment, facilities utilities, manufacturing equipment) Proficient in Microsoft Word, Excel, Power Point, and Project Ability to plan and manage own work All candidates must be legally eligible to work in India

Job Role: Supplier Quality Engineer Duration: 3 months contract Top 3 skills are: Experience with maintaining supplier qualification documentation within GxP systems Experience in creating and maintaining data reports for Supplier Quality function Proficient in Microsoft Excel. Requirements: Minimum 3 years of work experience, preferably in Quality within Pharmaceutical, Life Sciences, Medical Devices, or similar industry Bachelor's degree required Data administrative support for the Global Supplier Quality team including: Maintain weekly Supplier Quality data report in SharePoint Create and/or maintain Supplier Quality reports including monthly KPI bowler, quarterly PO/QSL report, etc. in SharePoint Maintain supplier certificates by monitoring expiration dates & obtaining updated certificates from suppliers to upload into supplier quality system of record Log and communicate supplier change requests upon receipt into specified trackers, as needed Support overall Supplier Quality Operations team with data maintenance in Supplier Quality system or creating/supporting project data reports, as required

GxP, GLP, regulatory environments Support Analyst Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applications supporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 2-3 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control

The Technical Architect will have to be execution-focused, supporting the full implementation lifecycle, from scoping to deployment in an evolving ecosystem consisting of clients and partners. You will be responsible for successfully solutioning the enterprise application E2E, designing and building the Salesforce Industry-specific Life Sciences, Health industry solutions. As a Technical Architect, you will become a deep product expert with Industry Salesforce Life Sciences Cloud (including Health Cloud) applications, and work closely with our sales and delivery teams to ensure customer success. You will lead the technical design and implementation of Salesforce solutions, ensuring compliance with industry regulations (HIPAA, GxP, etc.) and alignment with business goals. The ideal candidate combines deep Salesforce expertise with a strong domain understanding of pharmaceuticals, biotech, medtech, or healthcare providers. You will maintain an ongoing comprehensive understanding of the cloud-computing ecosystem. Your responsibilities will include serving as the technical lead for Salesforce Life Sciences Cloud implementations, including Health Cloud and other related Salesforce products. You will architect and design scalable, secure, and high-performance Salesforce solutions that align with industry best practices and compliance standards (e.g., HIPAA, PHI, GxP). You will define and oversee data models, security architecture, API integrations (FHIR/HL7), and performance optimization strategies. Leading a team of developers, you will drive optimized solutions across multi-cloud implementations, ensuring seamless integration between Health Cloud, Service Cloud, and Experience Cloud and Omnistudio framework. You will lead functional and technical workshops, demonstrating leadership skills in designing, delivering, testing, and deploying. Expertise in User Journey preparations, User Story reviews, Data Modeling, Apex Design Patterns, LWC, and other modern UI techniques will be essential. As a trusted advisor to the client, you will drive conversations with their Enterprise Architects and business partners that shape the architectural vision and establish a program architectural roadmap. Guiding customers, partners, and implementation teams on how best to implement digital transformation with the Salesforce platform using Salesforce Industries will be a key responsibility. Establishing trust with customers" leadership, promoting and/or implementing standard processes with SFI and Salesforce, and building out sophisticated business processes using native Salesforce Industries technology and the toolkit of the platform and integration tools are also critical tasks. You will research, recommend, and implement AppExchange applications and Salesforce upgrades to help meet business needs. Successfully creating custom enterprise applications using Salesforce.com and integrating Salesforce.com with other enterprise systems will be part of your role. Working closely with Delivery Managers, Solution Architects, and directly with clients to architect technology solutions to meet client needs is also expected. Highlighting and leading risk areas in the solution in a proactive manner and committing to seeing an issue through to completion will be essential for this position. Qualifications: - 10+ years of experience in developing technology solutions. - 3+ years of experience in handling client-facing projects in positions of increasing responsibility in the context of systems development and related business consulting. - Expertise in one or multiples of Salesforce Health Cloud, Sales/Service/Experience Cloud, and Vlocity Omnistudio. - Proven experience architecting enterprise-level Salesforce solutions in the life sciences or Veeva product or healthcare industry. - Strong understanding of compliance and regulatory requirements including HIPAA, GxP, PHI, HL7, and FHIR. - Experience in the healthcare domain (Preferred) - Integration Architecture (Must have) - Platform Security (Must have) - Identity and Access Management / Integration Security - Sharing and Visibility (Must have) - Data Architecture and Management (Must have) - Architectural Design Patterns (Must Have) - Apex Design Patterns (Must Have) - Salesforce/Apex, Triggers, Lightning Flows, Lightning, LWC, and experience with modern web and mobile technologies (HTML, CSS, JavaScript, Web Components, others) - Salesforce Certification Preferred (Admin, Developer, Sales, and Service Clouds, Application Architect, System Architect) - OmniStudio Developer/Consultant - Health Cloud Certification (Good to have),

As a Solution Architect-SAP Production Planning at Percipere, you will be responsible for designing, building, and optimizing end-to-end SAP Manufacturing Processes for our customers" enterprise. You will lead large-scale transformation projects in the Manufacturing Workstream, leveraging your experience, including PP object data migration experience in S/4 HANA. Conducting systematic client workshops to drive and derive key design decisions with industry best practice recommendations will be a crucial part of your role. In this position, you will lead the engagement efforts at different stages, from problem definition to diagnosis, solution design, development, and deployment in large S/4 HANA transformation programs. Your responsibilities will include creating detailed designs and architectures, process artifacts, implementing solutions, and deployment plans. You will connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology. Developing and nurturing strong client relationships to be trusted strategic advisors will be essential. You will also drive RFx related activities and sales pitches when needed while contributing to Unit and Organizational initiatives and COEs. To be successful in this role, you should have 10+ years of SAP Manufacturing and domain experience. Your business process knowledge should cover various topics such as Manufacturing Master Data, Production Planning, Demand Management, Sales & Operations Planning, Material Requirements Planning, Manufacturing execution, Capacity planning & execution, Movement of Raw Materials & Goods, and Cost Management. Integration knowledge with Manufacturing Execution Systems and other planning tools is essential, along with integration aspects with other SAP modules. You should have at least three end-to-end implementation projects in S/4HANA and possess good knowledge in Logistics BPML and understanding of GXP and SOX requirements. Experience in driving business process workshops, Fit/GAP analysis, and post go-live activities is required, along with awareness of release governance processes and incident management tools. Furthermore, as an additional responsibility, you are expected to be a senior Functional Architect for SAP Programs, anchoring the engagement effort for assignments from business process consulting to solution design, development, and deployment for S/4HANA Production Planning. You will lead business transformation programs, guiding teams on project processes and deliverables. As a thought leader in the manufacturing domain, you will advise on architecture and design reviews, anchor business pursuit initiatives, and contribute to client training and in-house capability building. Your role will involve shaping value-adding consulting solutions that help clients meet the changing needs of the global landscape. Basic knowledge in SAP PPDS, SAP IBP, SAP Quality Management, SAP aATP, deal pricing, transformation deal estimations, ABAP, Fiori, and technical know-how will be beneficial. Experience in working in a global delivery model will also be an advantage. If you are ready to take on this challenging and rewarding role as a Solution Architect-SAP Production Planning at Percipere, visit our website at www.percipere.co or contact us via email at careers@percipere.co.,

Alkem Laboratories Limited is an Indian multinational pharmaceutical company based in Mumbai, specializing in the manufacturing and distribution of pharmaceutical generics, formulations, and nutraceuticals across India and over 50 countries globally. Renowned for its top-tier pharmaceutical brands like Clavam, Pan, Pan-D, and Taxim-O, Alkem has consistently secured a position among India's top five pharmaceutical companies. As the IT Business Partner for SCM & Logistics at Alkem, your primary role is to serve as a strategic technology advisor, ensuring that IT solutions are aligned with the company's business objectives for the Supply Chain and Logistics functions. Your responsibilities include optimizing supply chain operations, enhancing logistics processes, and ensuring compliance with pharmaceutical industry regulations. Key responsibilities of the role involve: - Acting as the main IT liaison for Supply Chain, Procurement, and Logistics teams, translating business requirements into strategic IT roadmaps. - Developing and implementing a digital transformation strategy for supply chain operations, focusing on visibility, cost optimization, and automation. - Ensuring IT systems adhere to Indian pharmaceutical regulations, global GxP standards, and data integrity policies to support compliance and operational efficiency. You will be instrumental in: - Leading the enhancement of SAP S/4HANA SCM and IBP solutions to streamline supply chain operations. - Driving warehouse automation through technologies like IoT, RPA, RFID, and AI/ML-based demand forecasting. - Enabling real-time tracking of raw materials, inventory, and finished goods using supply chain analytics and predictive modeling. Your role also includes: - Optimizing inventory management, demand planning, and supplier collaboration through IT-driven insights and analytics. - Supporting serialization, Track & Trace, and regulatory compliance using blockchain or digital ledger technologies. - Improving order fulfillment rates and reducing logistics costs through the implementation of digital tools and automation. Moreover, you will: - Collaborate with SAP partners, IT vendors, and third-party logistics providers to ensure seamless integrations and high system availability. - Work closely with cross-functional teams including manufacturing, procurement, quality, and finance to drive supply chain enhancements. - Establish and maintain robust governance for IT projects, budgets, and vendor SLAs related to supply chain operations. The ideal candidate will possess: - A Bachelor's degree in Computer Science and a Master's degree in Supply Chain Management. - Over 10 years of experience in SCM & Logistics IT leadership roles within the pharmaceutical manufacturing sector. - Proficiency in SAP S/4HANA SCM and any Supply Chain Forecasting tool. - Hands-on experience with automation technologies such as RPA, AI/ML, IoT, and logistics analytics. - Strong knowledge of compliance standards including GMP, GxP, US FDA, EU GMP, CDSCO, and serialization. - Exceptional stakeholder management, project management, and vendor negotiation skills.,

Follow applicable departmental Standard Operating Procedures and Work Instructions. Complete required training according to required timelines. Audits System Life Cycle (SLC) activities and documentation. Plan, conduct, and lead global internal facility, system, and process audits. Plan, conduct, and lead external audits of vendors and suppliers. Participates in client and regulatory visits as the subject matter expert in the field of computerized systems and technology compliance. Author and review controlled documents including but not limited to SOPs and policies. Advises internal business, IT, and QA partners on systems and technology compliance. Leads and actively contributes to process and continuous improvement projects. Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed. Other duties as assigned by management. Qualifications (Minimum Required): A minimum of a bachelor's degree in Life Sciences preferred (or equivalent Life Science experience). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): 4 years in regulatory environment (system compliance experience). Must have a sound understanding of standard computer system development life cycles to provide necessary guidance to both information technology and operational personnel. Thorough knowledge and understanding of GxP and computerized systems regulations and regulatory guidelines. Experience applying regulations in at least one GxP discipline and computerized systems standards to the conduct of drug development. Ability to confidently interact with clients and regulatory personnel. Ability to conduct effective training. Ability to effectively negotiate ideas and suggestions. Strong analytical, organizational, and interpersonal skills. Preferred Qualifications Include: A minimum of a bachelor's degree in Life Sciences preferred (or equivalent Life Science experience). Physical Demands/Work Environment: Working hours : 2- 11 PM IST (2nd shift hours) Tasks involve sitting in front of a terminal for many hours during the working day. Some overtime and weekend work may be required. Travel Required Regionally up to 5% of the time.

Execution of IQ, OQ and PQ for new equipment, facility & utility system, report preparation and maintenance of record. Execution of Periodic performance verification activities for equipments, facility, utilities and its report preparation. Review Initial qualification master document like URS, GxP assessment, DQ, FAT, SAT, IQ, OQ, PQ and PPV of EFU system and all executed report. Handling of departmental QMS activity through track wise software, discrepancy / deficiency activity compliance of observation, summary preparation for regulatory submission. Qualification and Periodic performance verification activity execution, compilation, review of reports [Filter integrity test (PAO), air velocity, non-viable particle count, air flow pattern as per define schedule, review of calibration certificate for measuring devices]. Ensure and updation of periodic performance verification, calibration, Bulk SIP and smoke study schedule as per available data. Review of all AHU PAO test and NVPC report form for periodic verification, Filter Replacement intimation form, Equipment/instrument inward & Deletion intimation slip & all equipments print reports during qualification. Preparation of master document for periodic performance verification of EFU system Preparation & review of SOPs through EDMS Software Execution of FAT and SAT of equipment, facility and utilities as per requirement. Equipment Periodic performance verification schedule preparation, review, updation and provide data required for monthly report preparation. QE related Instrument calibration schedule preparation (Ellab wireless system, Ellab wired system, Rotronic data loggers certificate review and updation as per available data

This role is responsible for managing the external vendor and partner engagements, as well as product and program management and communication efforts for the Technology & Systems team of the Patient Safety and Pharmacovigilance (PS&PV) function This role ensures the successful execution of programs and operations of technology products in line with strategic and operational goals and maintains effective collaboration with external partners as well as with internal stakeholders Major accountabilities: Develop and maintain strong relationships with key strategic partners and vendors for Technology delivery for PS&PV Advise function leadership on best practices for supplier engagement and strategy Leverage partner capabilities to deliver differentiated PS&PV technology products and services based on knowledge of internal system architecture needs and strategic evolution, as well as external trends and best practices Actively oversee the engagement of key service providers in collaboration with the Procurement function, monitor vendor performance, and ensure adherence to contractual agreements Provide leadership and guidance for key strategic programs in PS&PV by applying best practices in project and program management Identify and mitigate risks and issues in program and project execution, as well as day-to-day operations Lead the application of enterprise-level Program Management Governance framework and best practices within PS&PV programs Serve as the change management and communication lead for the Technology & Systems team within PS&PV Deliver timely updates on project and operational milestones, achievements, issues, and risks to relevant stakeholders Oversee training curricula and capability-building initiatives for the Technology & Systems team based on a thorough understanding of organizational strategy and priorities Key Performance Indicators Strength and effectiveness of vendor relationships Successful execution and delivery of PS&PV projects and programs within scope, time, and budget Effective risk and issue management in project execution Quality and timeliness of communication with stakeholders Capability advancement for Technology & Systems team Work Experience: Minimum of 5 years of experience in a Senior Technology or Business role within the Life Sciences industry Experience in technology vendor management in a multi-national corporation Proven ability to manage complex projects and programs Strong relationship-building skills with partners and vendors Strong communication and presentation skills Ability to manage multiple priorities and work effectively in a fast-paced environment Experience in change management and driving organizational improvement initiatives, including organizational capability building Preferred : Knowledge of business processes in Patient Safety and Clinical Development and thorough understanding of GxP requirements Languages Fluent in spoken and written English

Job Summary: We are seeking a meticulous and detail-oriented Quality Checker to join our packaging artwork team. The role requires thorough experience in reviewing packaging artworks for compliance, consistency, and accuracy. The ideal candidate should be familiar with Adobe Creative Suite tools and artwork validation workflows in regulated industries like pharmaceutical or CPG/FMCG domains. Role & responsibilities Verify packaging artwork files against technical briefs, regulatory standards, and brand guidelines. Check alignment, font consistency, spelling, and layout accuracy in Illustrator and InDesign files. Compare artwork revisions using visual comparison tools or side-by-side manual methods. Validate correct Pantone, CMYK, and black/white color usages as per print specifications. Ensure images and logos are high-resolution, color corrected, and placed correctly. Track version history and ensure all changes are properly implemented and approved. Collaborate with designers, regulatory, and project managers to resolve discrepancies or errors. Support final quality checks before prepress or print delivery. Document QA feedback, maintain checklists, and prepare reports on defects or non-conformities. Support towards RCA/CAPA Preferred candidate profile 3+ years of experience in packaging artwork QA or Quality control with process improvement suggested based on the errors identified against Designers/Artworkers Strong knowledge of Adobe Illustrator, InDesign, and Acrobat for visual checks (Mandatory) Familiarity with color formats (Pantone, CMYK, RGB) and prepress compliance Ability to detect layout errors, font mismatches, bleed/trims, and inconsistencies Good communication skills for documenting and escalating issues Understanding of regulatory packaging standards (especially in Pharma or CPG/FMCG) Proficiency in using markup tools, comparison software

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Life Sciences Good to have skills : Salesforce DevelopmentMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time educationDeep expertise in Life Sciences (LS), Veeva CRM, LWC ,Agentforce, and strong Salesforce technical capabilities:Job Summary :We are seeking a Senior Salesforce Technical lead to join our Life Sciences Cloud team. The ideal candidate will have strong hands-on expertise in Salesforce platform development, solid understanding of life sciences commercial processes, and deep working knowledge of Salesforce ,Veeva CRM and Agentforce. This role is pivotal in designing and delivering scalable Salesforce solutions tailored for pharma field teams, HCP engagement, and compliance-driven operations.Key Responsibilities:Lead the technical design, development, and deployment of Salesforce solutions for life sciences commercial use cases.Work extensively on Agentforce modules for Pharma.Ability to put together over all architecture and suggest best practices for salesforce and Life science .Develop robust, scalable Apex, LWC, flows, and triggers aligned with Salesforce best practices.Integrate Salesforce with external systems such as Veeva CRM, MDM, IQVIA, MedPro, etc.Ensure solutions adhere to compliance and regulatory standards like HIPAA, GxP, and FDA transparency requirements.Guide junior team members and contribute to code reviews, DevOps (Copado/Gearset), and CI/CD pipelines.Participate in Agile delivery (Scrum) and maintain documentation aligned with validation/compliance processes.Required Skills: 810 years of Salesforce development and solutioning experience in Life Sciences domainStrong technical expertise in:oApex, SOQL, SOSL, LWC, Flow BuilderoREST/SOAP integrations, Platform EventsoCustom metadata and modular architectureHands-on experience with Agentforce (or equivalent field force automation)Proficient with Veeva CRM, including its data model, configuration, and integration touchpointsExcellent understanding of Life Sciences commercial processes:HCP engagement, field force operations, sample drops, complianceExperience working with DevOps tools (Copado, Git, Gearset) and Salesforce deployment lifecycleAbility to work with onshore-offshore delivery models and cross-functional teamsPreferred/Bonus Skills: Exposure to Salesforce CRM Analytics, Maps, or Einstein features used in life sciencesFamiliarity with Veeva Vault, Veeva My insights ,Salesforce Health Cloud, or LS Cloud industry add-onsKnowledge of validation documentation, GxP-aligned SDLC, or Part 11 audit trailsExperience on large scale data migration .Certifications (Required/Preferred):Salesforce Platform Developer I (Required) Salesforce Platform Developer II (Preferred)Salesforce Health Cloud (Preferred) Veeva CRM Configuration Certification (Preferred) Salesforce App Builder / Integration Architecture Designer (Nice to have) Additional Information:- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

The Director of Product Engineering will play a key role in leading the strategy and development of our Patient Safety software in the life science sector. Your responsibility will be to ensure that our products not only meet the evolving needs of our clients but also excel in functionality, market relevance, and user satisfaction. Success in this role is defined by delivering products that are industry-leading, enhancing user engagement, and achieving strategic business objectives. You will lead the product life cycle from conception to launch, aligning product vision with customer needs and business goals. Conducting market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector will be crucial. Collaborating with engineering, sales, and customer support teams, you will define and prioritize product requirements, features, and functionalities to meet customer demands. Developing and maintaining product roadmaps, ensuring clear communication and alignment across stakeholders, will be part of your responsibilities. Monitoring and evaluating product performance metrics, adjusting strategies as needed, and fostering relationships with key clients and industry experts for continuous product improvement are also key aspects of the role. Ensuring compliance with industry regulations and standards, managing product forecasts, budget, and driving efficiency into teams are essential tasks. To qualify for this role, you must have a Bachelor's degree in computer engineering or relevant experience in product management within the life sciences or software development industry. Proficiency in product management tools and methodologies, exceptional analytical and strategic thinking skills, and excellent communication and interpersonal skills are required. Experience in Agile Methodologies, managing diverse teams, knowledge of Gxp, and highly regulated environments are also necessary. Preferred qualifications include an advanced degree in Business, Life Sciences, or related field, experience in a startup or fast-paced environment, certification in Product Management or Agile methodologies, and a strong understanding of Patient Safety processes within the CRO industry. Additionally, having a technical background and the ability to think creatively and strategically when solving problems will be advantageous. This role offers the opportunity to drive innovation and continuous improvement in patient safety solutions, focusing on user-centered design principles to create an intuitive product. Understanding data, industry technology, and product trends in the Patient Safety space will be essential for success in this position. The work environment for this role is primarily office-based or hybrid, offering a dynamic setting to apply your skills and expertise in product engineering.,

Employment Type : On Contract _ till December 2026 Role & responsibilities: Lead Global GxP relevant IT Projects. Perform Global Quality Approval and Release of GxP relevant IT System Validations Manage, create, implement and maintain of harmonized STADA Global GxP Computer Validation System (CSV) Governance. STADA Global Quality Expert and CSV Champion to provide support to local, cluster and global teams in IT Validations in compliance with Health Authority requirements. Lead STADA Global GxP relevant IT Projects Lead Quality and other Business Teams in IT System Projects to ensure compliance with Health Authority requirements, such as, GxP and Data Integrity Prepare in collaboration with STADA Global IT highest level of Validation Governance documents, such as Validation Plans, in compliance with CSV regulations. Lead success closure activities of all required GxP relevant documents that are required for releasing the Global IT system for use/production. Present Projects to STADA Global Leadership members, including TechOps and Global IT Senior Vice Presidents and Global Quality Leadership Team. Global Quality Approvals and Releases Approve or ensure compliant approval process of Global GxP Validation key documents, including Validation Plan, URS, Risk Assessments, Testing Plans, Change Controls that are governing the GxP relevant IT System Validations. Approve and Release for use/production Global GxP relevant IT Systems, including but not limited to eQMS, EDMS, RIMS, LIMS and SAP. STADA Global Governance of GxP CSV Develop strategies to harmonize STADA Global approach on IT validation for GxP systems to ensure lean, efficient and compliant processes. STADA Quality Leader for Global CSV creation, implementation and continuous improvements. Identify any gaps of STADA Global CSV against Pharmaceutical Health Authority regulations, including but not limited to EU GMP Annex 11 and Data Integrity. Lead required enhancement initiatives to ensure compliance. STADA Global Quality CSV Expert and Champion Global Quality CSV expert during Health Authority Inspection, including all STADA operational sites and commercial affiliates. Quality Expert during customer audits at STADA. Quality Expert in STADAs audits at IT system service providers. Global Quality Expert for STADA GxP IT Validation Project Managers, System Owners, Business Owners, Process Owners and Key Users. Global Quality Expert to STADA internal and external clients on any GxP CSV related enhancement initiative and resolution of identified issues, including Data Integrity. Provide training to internal STADA customers related to GxP relevant electronic systems. Preferred candidate profile: Minimum 5+ years of experience in Pharmaceutical Quality IT role. Strong knowledge on GxP and Pharmaceutical Health Authority requirements on Data Integrity, electronic and automated systems, including EU GMP Annex 11. Strong experience in GAMP principals or similar. Experience in latest IT developments, including Cloud solutions Proven experience in leadership and in execution of GxP relevant IT systems. Proven experience in providing training on electronic systems and relevant Quality regulations. Experience in Global electronic and automated systems, preferable with SAP, EDMS, LIMS. Experience with matrix organizations and either in European or global position Fluent English Ability to work directly with Global Quality Leadership members including Global Senior Vice President, other Global and Cluster Heads, Global Project leads, Subject Matter Experts and project team members. Proactive, self-driven, highly motivated, takes responsibility seriously, cooperative, able to work under pressure Good communicator, excellent soft skills Ability to structure complex facts in an understandable fashion Willingness and capability to take decisions Technical understanding of electronic and automated systems Qualification : Graduation / Post Graduation in Pharmacy, Natural sciences, Engineering or equivalent, or long-term experience in the pharmaceutical industry

As a Solution Architect with expertise in SAP Manufacturing, you will be responsible for designing, building, and optimizing end-to-end SAP Manufacturing Processes for customers" enterprises. Your role will involve leading large-scale transformation projects within the Manufacturing Workstream, leveraging your experience in PP object data migration in S4HANA. You will conduct systematic client workshops to drive key design decisions, providing industry best practice recommendations. Throughout the engagement process, you will lead efforts from problem definition to diagnosis, solution design, development, and deployment in large S4HANA transformation programs. Your responsibilities will include creating detailed design and architecture artifacts, implementing solutions, and developing deployment plans. In addition, you will engage with senior client business and IT stakeholders, showcasing thought leadership in domain process and technology. Building and nurturing strong client relationships to become trusted strategic advisors will be crucial. Your role will also involve driving RFx related activities and contributing to unit and organizational initiatives and COEs. In terms of technical requirements, you should have at least 15 years of SAP Manufacturing domain experience. Your business process knowledge should cover areas such as Manufacturing Master Data, BoM, Recipe Routings, Work Centre, Production Planning, Demand Management, Sales Operations Planning, Material Requirements Planning, Manufacturing Execution, Capacity Planning Execution, Movement of Raw Materials Goods, and Cost Management. Integration knowledge with Manufacturing Execution Systems, 3PL, and other planning tools is essential, along with integration aspects with other SAP modules. You should have experience in at least three end-to-end implementation projects in S4HANA and possess good knowledge in Logistics BPML, understanding of GXP, and SOX requirements. Experience in driving business process workshops, fit-gap analysis, post go-live activities, and familiarity with release governance processes is required. Furthermore, additional responsibilities may involve SAP PP Manufacturing with Pharma Process Industry experience. You are expected to be a senior Functional Architect for SAP Programs, anchoring the engagement effort from business process consulting to solution design, development, and deployment for S4HANA Production Planning. Your role will include leading business transformation programs, guiding teams, advising on architecture and design reviews, and contributing to pursuit initiatives and client training. Having S4HANA Certification, basic knowledge in SAP PPDS, SAP IBP, and other industry-leading planning tools, as well as experience in SAP Quality Management, SAP aATP, deal pricing transformation, deal estimations, ABAP Fiori technical knowledge, and working in a global delivery model, will be advantageous. Your role will provide you with the opportunity to shape value-added consulting solutions that help clients meet the evolving needs of the global landscape. Your expertise in SAP PP will be pivotal in driving successful outcomes for both clients and the organization.,

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities SAP ISU Architect with Utility Industry experience. The candidate is expected to play the role of an expert level solution architect and leader covering the necessary process and technology options in large SAP CR&B accounts and transformation programs. The candidate should have good experience across electricity, Gas or Water Utilities industries, and should be experienced and adept at S/4 HANA. As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs. Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan. Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology. Contribute to Unit and Organizational initiatives and COEs Additional Responsibilities: Ability to lead large programs and diverse teams across the geographies Ability to lead and present proposals and solutions Strong Client Facing experience, great communication and presentations skills Strong analytical and decision-making skills Experience in working in Global delivery model (GDM) Ability to lead quality initiatives Technical and Professional Requirements: 12+ years of relevant SAP & domain experience Strong domain knowledge and good understanding on Meter to Cash processes - SAP ISU / CRM / C4C and other CX products including the customer service functions both in regulated and deregulated market with multiple suppliers and working modes. In depth knowledge and experience in ISU modules like Device management, Billing, FICA, IDEX etc and in Industry Solutions for Utilities. Experience in latest technologies involving SAP ISU like MCF, BRF+, Fiori Apps, BRIM (Convergent charging/invoicing), etc. Understanding & experience of Device & Billing concepts like AMI, EDM, ToU & RTP Billing Good understanding of GXP and SOX requirements. Preferred Skills: Technology-SAP ISU Billing-SAP IS- Utilities

Educational Requirements Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEsing potential problems (environments include Sandbox, Development, QA and Production). Additional Responsibilities: SAP BASIS with experience in any of the following industry (Pharma, Professional Services, Utility, Telecom, Oil and Gas/Public sector/Resources). The candidate is expected to play the role of an expert level Functional Solution Architect in large SAP transformation programs. The candidate should possess strong domain knowledge in Finance and should be experienced and adept at S/4 HANA SAP BASIS module with hands-on expertise. S4 HANA Public Cloud module with hands-on expertise is an added advantage. Proactive approach to problem solving. Good understanding of GXP and SOX requirements Experience in working in Global delivery model will be an added advantage. Excellent team management skill High analytical skills A high degree of initiative and flexibility High customer orientation High quality awareness Technical and Professional Requirements: Minimum 15-year experience with at least 10 years in SAP BASIS. Strong hands-on experience in S/4 HANA and HANA as a database for SAP applications Working experience of SAP applications on Hyper-scalers like AWS, Azure or GCP – reference architectures, native cloud services, compute and storage options for SAP applications, monitoring performance on the cloud Strong experience in SAP migrations – OSDB migrations, HANA migration & Conversion using DOC, DoDMO. Ability to optimize migration/conversion configurations to minimize technical downtime Knowledge of technical integration scenarios between cloud and on premise and between cloud and SaaS applications Experience in Designing & Implementing landscape architecture and sizing for S/4 HANA projects. Hands on experience in SAP BASIS tasks such as Support package and version upgrades, Client Strategy, Problem management and Capacity Planning including EWA analysis Preferred Skills: Technology-SAP Technical-SAP Basis

Job Location: Bangalore Qualification: Diploma or Degree in Engineering Experience: 2-4 years with Pharma Background Work profile: Plant IT operations Pharma and Biotech companies Installation of OS and application-level critical updates, Service packs, and security patches on workstations. Performance monitoring of all Servers, Desktops, and Networking devices. Installation and troubleshooting of operating systems and software, ensuring efficient deployment and resolution of issues. Applying the OS patches and upgraded administrative tools, maintaining the latest system updates and utilities for optimal performance and security. Remote support to end-users for enterprise-level applications, addressing technical issues and maintaining operational continuity. Configuration of software, peripheral devices, and upgradation and troubleshooting for enterprise applications hosted on Windows servers. Capable to handle GxP and non-GxP incidents and tickets related to backups, file management, user management, and security within SLA, and hardware and software maintenance to improve network performance and reduced downtime. Coordination with cross functional team for requirement gathering, review and finalizing technical specifications for IT infrastructure systems. Basic understanding business requirements from users. System administration for GxP application users and project Creation/Disable/modification records. Maintain the disaster recovery plan and backup. Should have good knowledge of QMS process include handling investigations, Change controls and deviations. Backup and Restoration for GxP Systems for Laboratory and Mfg. systems. Should be capable to Coordinate with external engineers/vendors of QC and ensure the services of equipment and applications. Provide technical and functional support to the teams, maintaining the team and giving support to end users for day-to-day activities along with reviewing team Daily reports weekly reports, and Monthly reports and preparing necessary documents. Configuring and troubleshooting of the Network and printers, Configuring and troubleshooting of LAN on Windows platforms. Installation and troubleshooting of Desktops and Workstations.

Supplier Quality Data Analyst Duration: Sept 1, 2025 Nov 30, 2025 Location: Remote (Bangalore, India-based) Work Hours: 40 hrs/week, 8 AM – 5 PM EST (flexible) Interview Process: 1 Virtual Round Team: Global Supplier Quality – Operations Pay: 12/hr USD – (41,000 to 42,000/week in India) Role Overview The selected candidate will support the Global Supplier Quality Operations Team with a 50/50 focus on data analytics and quality documentation within a GxP / GMP-compliant environment , using Veeva and Excel-based systems. Responsibilities Maintain and update weekly KPI reports , quarterly performance reports , and supplier quality data sets . Handle supplier qualification documents , including ISO , GxP , and GMP certificates. Monitor expiration dates and request renewals from suppliers. Pull weekly data from supplier quality systems , analyze for errors, and track performance metrics. Manage and track supplier change requests . Upload, monitor, and maintain documents using Veeva software. Conduct data assessments , error tracking , and assist in compliance reporting. Work closely with cross-functional teams during on-the-job training and process ramp-up. Must-Have Skills & Requirements 3+ years experience in documentation or data quality support roles. Strong hands-on experience with MS Excel (reporting, error-checking, formatting). Familiarity with GMP / GxP / ISO compliance environments (Pharma or Medical Device preferred). Working knowledge of Veeva or similar document control systems. Ability to read and understand specifications and track supplier compliance . Comfortable handling data integrity , compliance documentation, and internal reporting tasks. Working 50% Quality Documentation & Compliance 50% Data Analytics & Reporting

Role & responsibilities Scrum master should be able to create the environment for a team to deliver value, be highly independent, confident in their abilities and flexible enough to adapt to an evolving landscape. Responsible for ensuring Scrum is understood and the team adheres to Scrum practice, and guidelines. Works with Multiple Scrum Teams , as well as internal and external stakeholders, to influence and drive decision making and support organizational project or product teams. Facilitates and supports all scrum events: Sprint Planning, Daily Scrum, Sprint Review, and Sprint Retrospective. Removing impediments or guiding the team to remove impediments. Facilitating discussion, decision making, and conflict resolution. Supporting and educating the Product Owner, especially on grooming and maintaining the product backlog. Providing all support to the team using a servant leadership style whenever possible and leading by example. Scrum is understood and the team adheres to Scrum theory, practice, and guidelines. Good skills and knowledge of servant leadership, facilitation, situational awareness, conflict resolution, continual improvement, empowerment, and increasing transparency. Adept at refinement, story splitting, estimation, velocity, retrospection , and other Scrum techniques. Planning and problem-solving involving product management and delivery teams. Assisting with internal and external communication, improving transparency, and radiating information on team performance and progress using key Agile metrics. Working with the Product Owner to align team with product vision and sprint goals and participate in product backlog preparation activities. Mitigate risks and communicate to leaders using best practices in Agile. Instill continuous improvement activities to reduce waste and increase productivity. Leverage skills from coaching, facilitation, conflict resolution and more to guide teams to embrace Agile mindset. Handle the escalations and conflict within the project team. Experience working with geographically dispersed clients. Excellent communication and articulation skills. Preferred candidate profile 6-9 years of experience as a Scrum Master Life sciences/Pharma domain experience is a must Proven experience managing technology transformation, digital health, lab systems (e.g., LIMS, ELN), clinical systems (e.g., CTMS), manufacturing systems or similar. Strong understanding of regulatory environments and compliance standards (FDA, GxP, CSV, etc.). Good understanding of industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Hands on experience as Scrum Master/ Agile Project Manager for at least for 3-4 years. Hands on experience in Software Life Cycle (SDLC), waterfall, hybrid and agile projects Experience in using Scrum, Kanban, SAFe, Lean Agile frameworks. Experience in Project Management tools such as JIRA, ADO etc. SAFe/ CSM / PSM equivalent certification. Bachelors in Engineering / MBA. PMP certification, Agile or SAFe certification preferred. The experience in applying a wide variety of well-documented patterns and techniques to enhance the Scrum approach (e.g. Estimation Techniques, progress visualization techniques, retrospective formats, approaches for handling bugs , etc.). Excellent communication skills, both written and verbal Excellent coaching and mentoring skills

Role & responsibilities Lead end-to-end project management for IT/technology initiatives in the pharma/life sciences domain, ensuring timely delivery and within budget. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Commercial teams. Define project scope, objectives, deliverables, milestones, and timelines. Manage vendor coordination, software implementation, system integration, and infrastructure deployments. Ensure alignment of projects with industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Prepare detailed project plans, status reports, risk mitigation strategies, and issue logs. Act as a single point of contact for stakeholders, ensuring effective communication and expectation management. Facilitate change management, training, and adoption strategies. Ensure adherence to internal project governance, compliance, and validation procedures. Preferred candidate profile 1012 years of total experience in IT/Technology Project Management, with at least 5 years in the Pharma/Life Sciences domain. Proven experience managing technology transformation, digital health, lab systems (e.g., LIMS, ELN), clinical systems (e.g., CTMS), manufacturing systems or similar. Strong understanding of regulatory environments and compliance standards (FDA, GxP, CSV, etc.). Hands-on experience with Agile, Scrum, or Hybrid delivery methodologies. Ability to manage cross-functional teams and third-partyvendors. Excellent communication, stakeholder management, and leadership skills. PMP/Prince2/CSM certification is a plus Good To Have Experience with data platforms, analytics in pharma, or AI/ML initiatives in life sciences. Exposure to cloud migrations, enterprise platformslike SAP, Veeva, Oracle Health Sciences, etc. Prior experience with global project rollouts across geographies. Understanding of pharma manufacturing processes, quality control, or clinical development lifecycle

Responsibilities: Manage CSV projects from start to finish. Ensure compliance with GAMP, GDP, CapA, GXP, IT Compliance & LIMS standards. Collaborate with cross-functional teams on system validation. Free meal Cafeteria Food allowance Shift allowance Over time allowance Travel allowance Sales incentives Annual bonus Performance bonus Marriage & childbirth gifts