192 Fda Jobs

The Plant Manager will play a crucial role in overseeing all operational aspects of a natural product extraction and food processing facility. Your responsibilities will encompass managing production, quality control, maintenance, and distribution to ensure compliance with safety regulations and operational efficiency. Your pivotal role in achieving productivity, cost-effectiveness, and continual improvement in plant operations will be instrumental in upholding the highest standards of food safety and product quality. In terms of Production & Operations Management, you will be tasked with supervising daily operations to facilitate smooth and cost-effective production aligned with organizational objectives. It will be essential to strategize, monitor, and enhance production schedules, resource allocation, and material flow. Driving enhancements in plant efficiency, yield, waste reduction, and operational costs will be a core aspect of your responsibilities. Furthermore, ensuring strict adherence to Standard Operating Procedures (SOPs) across all departments will be critical. As for Quality & Food Safety, you will lead the implementation of various food safety systems, including cGMP, HACCP, FDA, FSSAI, HALAL, KOSHER regulations, certifications, and standards throughout the facility. Upholding internal quality benchmarks and customer specifications for all finished products will be imperative. Establishing robust quality control systems, conducting root cause analysis to address deviations, and personally taking charge of corrective actions in the event of critical non-conformities will also fall within your purview. Additionally, you will be responsible for overseeing regulatory and customer audits and ensuring meticulous documentation for the same. In terms of Budgeting & Cost Control, collaboration with the finance team to develop annual operating budgets will be paramount. Monitoring and managing costs across various domains such as production, labor, maintenance, and utilities to align with budgetary targets will be crucial. Identifying opportunities for cost savings through process optimization and waste minimization will also be a key focus area. When it comes to New Product & Process Development, you will be expected to support the scaling up of new products from R&D and Sales, with a keen eye on ensuring commercial viability. Collaborating with cross-functional teams to trial and implement innovative extraction and processing technologies will be essential for driving continuous growth and innovation within the facility. To qualify for this position, you should hold a Masters or Bachelor's degree in Chemical Engineering, Chemical Technology, Food Technology, Biotechnology, Chemistry, or related disciplines. A minimum of 12 years of industry experience, including at least 5 years in a leadership role within food processing, food ingredient manufacturing, Nutraceuticals, or natural product extraction, is required. Demonstrated expertise in managing plant operations, production teams, and quality systems is essential. Sound knowledge of cGMP, HACCP, FDA, FSSAI, HALAL, KOSHER guidelines, and regulatory frameworks will be advantageous. Preferred experience includes prior involvement in fruits, vegetables, herbs, extraction and purification, or plant-based ingredient processing. Exposure to solvent extraction, spray drying, concentration, milling, conveying, blending, and packaging technologies will be considered beneficial for this role.,

You will be responsible for developing, customizing, and maintaining applications for Oracle's JD Edwards management system to meet the specific requirements of clients. Your role will involve analyzing requirements, designing solutions, and utilizing appropriate development tools. It is essential to have 5-7 years of experience in participating as a developer for Oracle's JD Edwards ERP software, including implementations and migrations. You will be expected to conduct technical analysis of functional requirements, develop customized applications and solutions, and create localizations based on new legal resolutions. Your responsibilities will also include designing, developing, and customizing user interfaces, executing tests for applications, and documenting design, programming, and procedures. Additionally, you will be required to prepare technical documentation to contribute to user documentation, provide maintenance and support for applications, and resolve incidents while monitoring for any issues. Experience in implementing circuit improvements and preparing pre-production and production environments for implementation of developments will be valuable. The ideal candidate should have a background as a Systems Professional, Systems Engineer, Systems Graduate, or Programmer. Proficiency in JD Edwards Enterprise One (versions from XE to 9.2) is essential, along with knowledge of various technical aspects such as Media Objects, Table triggers, UDC, NER, C/C++ BSFN, UBE's, FDA, RDA, OMW, Power Forms, DEBUG, DEBUG C, EDIS, and Log interpretation. Strong programming skills in JDE Toolkit, C, C++, and PL/SQL are required, along with experience in Agile methodologies, BI Publisher, Oracle, SQL Server, testing tools, and operating systems like Linux and Windows. The successful candidate should possess technical English skills (minimum requirement), with intermediate/advanced English proficiency being desirable. Key competencies for this role include responsibility, proaction, sense of urgency, adaptability, critical thinking, analytical capacity, problem-solving skills, attention to detail and the whole, creativity, lateral thinking, teamwork, and effective communication.,

Skill required: KYC Screening - Sanctions Screening Designation: Regulatory Compliance Analyst Qualifications: BCom Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with KYC experience along with ECDD/OCDD knowledgeAbility to effectively and efficiently conduct the process of screening individuals, entities, or transactions against lists of sanctioned or restricted parties. Sanctions screening involves using specialized software, understanding relevant regulations, and maintaining a proactive approach to mitigate the risk of engaging with sanctioned entities. What are we looking for Commitment to qualityCollaboration and interpersonal skillsAbility to work well in a teamAbility to perform under pressureAbility to meet deadlines Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom

As an Executive / Senior Executive in Quality Control (QC), you will play a crucial role in ensuring that products consistently meet the defined quality standards of the company. Your responsibilities will include conducting quality testing of raw materials, in-process, and finished products as per Standard Operating Procedures (SOPs). It will be your duty to identify, document, and escalate any non-conformities or deviations found during testing, while maintaining thorough and accurate records of test results, logs, and batch documents. Your role will also involve ensuring alignment with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements. Collaboration with the production team to troubleshoot and resolve quality-related concerns will be essential. Moreover, you will be preparing and assisting in internal and external audits as well as regulatory inspections. Monitoring key quality metrics and providing inputs for process improvements are also part of your responsibilities. To excel in this role, you should have 2 to 5 years of experience in QC roles within the cosmetics, pharmaceutical, or FMCG industries. A strong technical understanding of quality control protocols, lab equipment, and analytical techniques is necessary. Knowledge of regulatory frameworks such as ISO, WHO-GMP, and FDA will be beneficial. Your detail-oriented mindset, coupled with strong documentation and analytical skills, will be key to success. Proficiency in handling quality management systems (QMS) and MS Office is essential. Effective communication and interpersonal abilities will also be valuable in this position.,

Job Title: Senior Regulatory Publishing Specialist Responsibilities:Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets.eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch.Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR.Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines.Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects. Qualifications:Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field. Experience: Minimum 3-6 years of hands-on experience within the CRO/Biotech/Biopharma industry. Expertise: Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation.Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels. Location - Madhapur, Hyderabad, Telangana, India 500081

SUMMARY Sr. Site Reliability Engineer Keep Planet-Scale Systems Reliable, Secure, and Fast (On-site only) At Ajmera Infotech , we build planet-scale platforms for NYSE-listed clients from HIPAA-compliant health systems to FDA-regulated software that simply cannot fail. Our 120+ elite engineers design, deploy, and safeguard mission-critical infrastructure trusted by millions. Why You’ll Love It Dev-first SRE culture automation, CI/CD, zero-toil mindset TDD, monitoring, and observability baked in not bolted on Code-first reliability script, ship, and scale with real ownership Mentorship-driven growth with exposure to regulated industries (HIPAA, FDA, SOC2) End-to-end impact own infra across Dev and Ops Requirements Key Responsibilities Architect and manage scalable, secure Kubernetes clusters (k8s/k3s) in production Develop scripts in Python, PowerShell, and Bash to automate infrastructure operations Optimize performance, availability, and cost across cloud environments Design and enforce CI/CD pipelines using Jenkins, Bamboo, GitHub Actions Implement log monitoring and proactive alerting systems Integrate and tune observability tools like Prometheus and Grafana Support both development and operations pipelines for continuous delivery Manage infrastructure components including Artifactory, Nginx, Apache, IIS Drive compliance-readiness across HIPAA, FDA, ISO, SOC2 Must-Have Skills 3 8 years in SRE or infrastructure engineering roles Kubernetes (k8s/k3s) production experience Scripting: Python, PowerShell, Bash CI/CD tools: Jenkins, Bamboo, GitHub Actions Experience with log monitoring, alerting, and observability stacks Cross-functional pipeline support (Dev + Ops) Tooling: Artifactory, Nginx, Apache, IIS Performance, availability, and cost-efficiency tuning Nice-to-Have Skills Background in regulated environments (HIPAA, FDA, ISO, SOC2) Multi-OS platform experience Integration of Prometheus, Grafana, or similar observability platforms Benefits What We Offer Competitive salary package with performance-based bonuses. Comprehensive health insurance for you and your family. Flexible working hours and generous paid leave . High-end workstations and access to our in-house device lab. Sponsored learning: certifications, workshops, and tech conferences.

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma in South Asia, ASEAN, ANZ Main Areas If Responsibility And Key Activities Regulatory Prepare and compile the checklist and documents for Active Ingredients, New application and renewal applications; Coordinate with global and regional regulatory on strategizing the approach for new and renewal application submission, authority deficiency questions and post approval variations Coordinate with global and regional regulatory for regulatory/quality documents support for customer requests Understand the gaps on the analytical questions from customers and provide interim or immediate support Establish an overview on upcoming and updated regulatory guidelines and identify the top focus topics for South Asia, ASEAN, ANZ Actively participate in the Regulatory process including monthly/ quarterly country calls, regional reporting and Global RA meetings Customer support Provide complete and timely support to internal and external customers on regulatory matters Industry representation Represent BASF Pharma at South Asia Pharma/Excipients associations (e-g IPEC India) Others Engage with South Asia sales head and sales colleagues to understand the business needs and potential Job Requirements Minimum Bachelor Degree in Science/ Pharmacy Minimum 5 years of regulatory and quality experience in pharmaceutical industry Understand India regulatory and US FDA guidelines Prior experiences in Regulatory Affairs/ Quality Control laboratory Team player with strong communication skills Can speak English and Hindi (preferred)

As a global leader in assurance, tax, transaction, and advisory services, we at EY are dedicated to hiring and nurturing the most passionate individuals in their respective fields, all in an effort to contribute towards creating a better working world. Our culture is rooted in the belief that every individual deserves the training, opportunities, and creative freedom essential for growth. At EY, we are not solely interested in your current capabilities, but in the potential of who you can become. We firmly believe that your career is yours to shape, with limitless possibilities awaiting you. Throughout your journey with us, we are committed to providing you with inspiring and fulfilling experiences that will aid you in evolving into the best version of your professional self. The position available is for a Senior Consultant in the National Forensics team, focusing on Forensics Discovery in Hyderabad. Your primary responsibilities will include showcasing technical excellence in the field, particularly in relation to FDA. To qualify for this role, you must possess the necessary qualifications and experience in FDA. We are seeking individuals who can collaborate effectively across various client departments, adhering to both commercial and legal standards. You should have a pragmatic approach to problem-solving, with the ability to offer insightful solutions to complex issues. We value individuals who are agile, inquisitive, mindful, and can maintain a positive attitude while also being adaptable and innovative in their problem-solving strategies. EY is proud to be associated with over 200,000 clients globally, with a workforce of 300,000 people worldwide and 33,000 employees in India alone. We have established ourselves as a leading brand and an employer of choice in our industry, showcasing exceptional growth and a commitment to excellence. Our team collaborates with influential entrepreneurs, game-changers, disruptors, and visionaries, providing ample opportunities for growth and development. We are dedicated to investing significant resources in skills development and learning initiatives for our employees. At EY, you will embark on a personalized Career Journey and have access to our comprehensive career frameworks to gain insights into your roles, skills, and potential opportunities. EY is deeply committed to promoting diversity and inclusivity in the workplace, ensuring that our employees strike a balance between delivering excellent client service and focusing on personal growth and well-being. If you believe you possess the qualifications and attributes outlined above, we encourage you to reach out to us promptly. Join us in our mission to build a better working world by applying now.,

Are you passionate about driving clinical quality and compliance Do you have a proven track record in clinical operations and a knack for innovation and process improvement If you're ready to take on a leadership role that makes a real impact, we invite you to explore this exciting opportunity, apply today for a life-changing career! As the Head of Clinical Operational Excellence, you will play a pivotal role in ensuring clinical quality, compliance, and operational excellence. Your key responsibilities will include performing risk assessments and trend analyses to proactively address clinical quality risks, ensuring audit and inspection readiness including CAPA documentation and stakeholder communication, representing the CDC in regional and global clinical quality forums, ensuring compliance with local regulatory requirements, coordinating Quality Management Reviews (QMR), developing and executing yearly training plans aligned with operational strategies, driving innovative solutions for operational efficiency such as digital visit tracking and RBQM, identifying and implementing process improvements, conducting stakeholder satisfaction checks, measuring the effectiveness of new processes, and communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO. To be successful in this role, you should have 15+ years of experience in clinical operations with a minimum of 3 years in clinical quality, 5 years of direct team handling experience with 360* performance management, completed qualifications in Medical, Pharmacy, Life Sciences, or another related field, a track record of driving innovation and process improvements in clinical operations, experience with digital tools and systems for operational excellence, excellent communication, and stakeholder management skills. The Clinical Development Centre (CDC) India is at the forefront of ensuring clinical quality and operational excellence. Based in a fast-paced and dynamic environment, the department proactively addresses clinical quality risks through risk assessments and trend analyses, ensures audit and inspection readiness, maintains compliance with local regulatory requirements, drives innovative solutions such as digital visit tracking and RBQM, represents CDC in global forums, and fosters collaboration with external regulatory authorities. With a culture of continuous improvement and a commitment to operational efficiency, the team thrives on delivering impactful results that make a difference. If you are interested in submitting your application, please upload your CV and motivational letter online. Internal candidates are kindly requested to inform their line Managers before applying. The deadline for applications is 01st Aug. 2025. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants. The company recognizes the importance of creating an inclusive culture that celebrates the diversity of employees, patients served, and communities operated in. Together, Novo Nordisk strives to be life changing.,

Function:PMSRole:Post Market SurveillanceDesired Skills:PMS, complaint handlingCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis Risk management Risk assessment. Required Candidate profile Propose strategies and solutions to data issues or challenges that occur during the PSUR writing and conclusion process.

Responsible for manufacturing of all types of Tablet / Capsule / Powder (FDA Approval Must) Responsible for timely delivery with Quality and Quantity Responsible for motivation and handling of manufacturing workforce New Product Development Conduct Technical Non Technical Trainings Manufacturing of Tablet Capsules (Ayurvedic Allopathy) Predict, handle and rectify manufacturing defects Man management skills Knowledge of GMP guidelines Efficient in Documentation 2 - 3 Yrs at junior / executive position of similar profile

You will be working as a Manufacturing Operator in the Pharma Solution business unit within the Operations department located in Lexington. Your primary responsibilities will include performing various production activities such as component preparation, filling, capping, autoclaving, compounding, and lyophilization production. You will report directly to the Manufacturing Supervisor. In this role, you will be required to comply with all relevant policies and procedures set forth by PPS and various regulatory agencies. Some of your key responsibilities will involve performing line clearances, cleaning and sterilization of equipment, operation of aseptic filling equipment, executing validation protocols, maintaining production records, and ensuring compliance with Good Manufacturing Practices and Standard Operating Procedures. To be successful in this position, you should have a high school education or equivalent qualification, along with at least 2 years of experience working in an industrial or manufacturing environment. Prior experience in pharmaceutical manufacturing or aseptic manufacturing is preferred. You should also possess mechanical aptitude, the ability to follow regulatory requirements, and be a team player committed to quality and collaboration. Your role will require you to operate and maintain production equipment, weigh and measure raw materials, maintain cleanliness in the work area, and collaborate effectively with other functional groups such as quality, validation, and supply chain. Additionally, you will be responsible for reviewing production documentation for quality and compliance, participating in troubleshooting activities, and providing on-the-job training for new operators. The Piramal Group, under which Piramal Pharma Solutions operates, is dedicated to inclusive growth and ethical practices. As part of the team at PPS, a Contract Development and Manufacturing Organization, you will contribute to providing end-to-end development and manufacturing solutions across the drug life cycle. The organization offers a wide range of services globally, including drug discovery, process development, clinical trial supplies, commercial supply of APIs, and specialized services for biologics. As a Manufacturing Operator, you will play a crucial role in contributing to the success of the production operations at Piramal Pharma Solutions. Your dedication to quality, regulatory compliance, and teamwork will be essential in achieving production goals and maintaining a high standard of manufacturing excellence.,

As an Analytical Chemist at Linde, you will utilize your knowledge of Quality control and GMP under FDA guidelines to ensure targets are met and plant parameters are optimized for maximum output and efficiency. Your role will involve ensuring compliance with local regulations and obtaining necessary approvals/licenses, particularly from the FDA. You will also play a key role in selecting suitable suppliers, agreeing on technical scope/solutions, conducting stage gate inspections for quality assurance, and assessing technical competency to assign tasks accordingly while ensuring safety and quality standards are maintained. Additionally, you will be responsible for making purchases for materials, assets, and services, as well as coordinating maintenance and troubleshooting activities. Your contribution will be vital in implementing directives, alerts, and improvement initiatives, as well as developing and sharing Root Cause Analysis reports. To excel in this role, you should hold a degree in B Sc Chemistry/BE/Bachelor of Pharmacy or an equivalent qualification, coupled with a minimum of 5 years of experience in the relevant field. Your ability to ensure compliance with local regulations and obtain necessary approvals/licenses, especially from the FDA, will be crucial to your success in this position. Linde is a globally renowned industrial gases and engineering company with operations in over 100 countries. We are committed to making the world more productive by providing high-quality solutions, technologies, and services that empower our customers, drive success, and contribute to the sustainability and protection of our planet. The joint venture between Linde India Limited and Praxair India Private Limited, LSAS Services Private Limited, aims to provide Operations and Management services to both entities while upholding a legacy of sustainable development and technological innovation in the industrial gases industry. As part of the Linde family, you will have limitless opportunities to realize your potential, make a positive impact, and contribute to a better world. Join us at Linde and embrace the limitless possibilities that lie ahead! If you are inspired by our vision and eager to be part of our dynamic team, we invite you to submit your complete application, including a motivation letter, CV, and certificates, through our online job market. Linde South Asia Services Pvt. Ltd. upholds a strong commitment to responsible business practices, technological innovation, and sustainable development across all its operations worldwide. We value diversity and inclusivity, and the language used here is intended for simplicity and clarity for all individuals.,

Job Responsibilities Operations Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning. Provide management and leadership direction for the development and implementation of quality and compliance programs. Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices. Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents. Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to clients QMS and quality training requirements. Responsible for ensuring that the work conducted by the Facilities team, and its subcontractors is in full compliance with contractual requirements, clients SOPs, GxP, FDA and other regulations. Able to perform/support internal JLL compliance audits and prepare SOPs, and training materials for use by the Life Sciences facilities team in the performance of their work. Guide Life Sciences facilities team in closing recommendations from clients audit. Expected to interface with the clients quality personnel to ensure that all of the clients SOPs are followed, work performed by the LS facilities team is properly documented for traceability in the framework of GDP. Sustain quality assurance support and develop a Quality Engineering Maintenance program for a controlled-environment manufacturing and laboratory facility as it relates to the facilities maintenance of this plant. Conduct investigations and drive accountability for all quality events. Lead programs to create value for client to ensure program deliveries meet or exceed expectations. Facilitate quality-relevance investigation via structured Root Cause Analysis. As part of career development, lead Life Sciences accounts as an IFM leader.Reporting Manage and report on critical & key performance measurements. Develop and submit periodic site status reports related to the Quality Program. People Management Effectively lead and guide a Life Sciences Quality team by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement. Ensure Life Sciences Operations team members complete relevant quality and compliance training. Coach new Life Sciences team members on quality and compliance for their adaptation into specific Life Sciences accounts. Mentor, develop and train peer and direct report team members. Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.Others Any other quality-relevant duties and tasks assigned. Knowledge, Skills & Abilities. MINIMUM REQUIRED / PREFERRED - Education/training Bachelor degree preferred Degree in science, technical or relevant discipline Sound fundamental knowledge in process utilities. 6+ Years of relevant experience preferred with minimum 4+ years in Quality and Compliance discipline in GxP manufacturing or laboratory environment. Six-Sigma and Root Cause Analysis training is essential. Skills and knowledge Background in technical documentation Work independently and within a team. Strong mindset of compliance and client-focus. Communicate effectively with technical, quality assurance and other personnel. Proficient in Word, Excel and other Microsoft Office Suite programs Ability to investigate, recognize and diagnose trends and patterns. Solid understanding of cGMPs as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing plants and laboratories for drug products. Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity. Support investigations and corrective action plans for appropriate discrepancies. Investigation of compliance issues as required, collaborating with relevant Compliance Partner(s) Understanding of FDA regulations including 210 CFR part 210 and 211. Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the site. Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems English communication is essential Other abilities Good oral and written communication skills including the ability to communicate to all levels of management and willing to interface with a diverse customer base including technical and non-technical personnel.Physical work requirements and work conditions Familiar with process utilities and GxP environment.

You will be responsible for reviewing and conducting chemical testing of raw materials, finished products, cosmetics, Ayurveda, Sidha & Unani products. You will need to accurately enter the test results into the LIMS software. Additionally, you will be required to handle instruments like HPLC, GC, FTIR, Dissolution, etc. Technical documentation in compliance with FDA, CDSCO & Ayush standards for audits will also be part of your responsibilities. The position is based in Gurugram and requires a minimum qualification of B.Pharma, M.Pharma, MSc. Chemistry or a related field. The ideal candidate should have 2 to 15 years of relevant experience.,

Greetings, Hope you are doing fine! NOTE: We apologize if any inconvenience is caused or if this job opening is irrelevant / not of interest to you and request you to ignore this mail. We have an job opening with a leading HealthTech company Position: Head of Compliance Location: Bangalore JD: Need a candidate having experience in Compliance, HIPAA, SaMD, and FDA. If interested in the profile, kindly send us your updated CV to debraj.bhattacharya@connexio.asia and ankit.kumar@connexio.asia Also, it would be great if you could help me with the following details Current Fix CTC: Expected CTC: Notice Period: Current Location: Thanks, Mona Shah Recruitment Team Email: mona.shah@connexio.asia

Role & responsibilities Shall be take care of process Equipments ( preventive Maintenance , Breakdown , QMS ) Preferred candidate profile Candiate should have very deep knowledge about preventive maintenance and breakdown activities pertaining process equipments. Also shold velwersed with QMS GMP activities.

Review SOP Support quality system Familiar with process/cleaning validation Assist internal & external audits Assist specification settings, OOS investigation, change controls, regulatory submission/update, annual product reviews, other investigation Required Candidate profile Must have min. 2 yrs experience & must be familiar with cGMP requirements. Candidate should have good knowledge of computer & ability to effectively interact with individuals at all levels.

Company: Yash Technology Location: Bangalore Experience: 6+ years Mode of work: Work from Office Type of employee: Full Time Employee Shift Timings: 12PM - 9PM Interested and relevant candidates share your profile to padma.ashwitha@gmail.com Essential Duties and Responsibilities: • Possesses solid understanding of overall vision and business needs and utilize specialized expertise to collaborate with Quality and Operations to define detailed User Stories for D&T enablement of business needs. This includes interpreting any issues and recommending solutions or best practices. • Utilizes knowledge of best practices to help define strategic direction, help determine business needs and design & deliver technical solutions for QA, in partner with Application and Infrastructure. • Essential core member of agile sprint team(s) to configure and develop optimal technical solutions / features. • Provide technical delivery of functionality to meet defined business requirements as described in User Stories. • Provide system support and maintenance in alignment with standards and process set within the ERP Services Delivery model, West policies and procedures as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. • Create and maintain system lifecycle documents in accordance with West policies and procedures, including creation and maintenance of SOPs, SOIs and Job Aids. • Work within and participates in the Change Control process. • Other duties as assigned. Education and Experience: • Bachelors degree or equivalent experience in Computer Science or Information Systems • 7+ years of related work experience, i.e. 3 or more full implementations of SAP QM solutions • Preferred but not required: Agile & Scrum Certification, ITIL . Knowledge, Skills and Abilities: • Solid SAP skills system functionality and technical understanding of QM and related areas (PP, MM, PM) • Must be up to date on latest ERP release. • Strong HANA knowledge preferred • Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment. • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description • Support and contribute in Lean Sigma programs and activities towards delivery of the set target • Able to comply with the companys safety and quality policy at all times. Physical and Travel Requirements: • 15% travel, including global travel • Occasional on-call work required • Prefer 12pm 9pm India time. Willingness to work outside of these hours as needed. Regards, P. Ashwitha

(We are looking fo the Immediate joining candidates or willing to leave early for their current company) Role & responsibilities HPLC Analysis of Solid Orals/Nasal hands on experience on QC activities, RM, Packing, In Process and Finished Products Compliance with GMP/GLP Practices Preferred candidate profile 2-7 years of experience Prior experience of working in Regulated plants (USFDA/MHRA Approved) Perks and benefits Working in a state-of-the-art fully automated world class manufacturing. Opportunity to work on diverse dosage forms in a multi-product facility. Attractive attendance bonus & Special Allowances Unmatched opportunities to learn and grow Thanks & Regards Dhivakar D BVR People Consulting dhivakar@bvrpc.com

As a Regulatory Affairs Coordinator at Cipla, your primary responsibility is to ensure timely approvals from the FDA (Loan License units) by effectively coordinating with internal stakeholders and FDA teams for the submission of various applications. Your role also involves developing strong relationships with external stakeholders and advocating for licensing approvals for Cipla LL products. Your key accountabilities include: - Securing timely regulatory approvals from State FDA and CDSCO offices for loan license units, which includes obtaining approvals for various applications such as fresh loan licenses, additional product permissions, test licenses, India Business Tender Certificates, WHO-GMP, COPP, etc. - Coordinating with internal stakeholders to ensure timely applications and resolution of queries for approvals. - Maintaining a master tracker list of all permissions/approvals for the FDA (LL) team. - Building and maintaining relationships with external stakeholders in FDA and CDSCO offices. - Monitoring the timely release of CMCL for local and export markets, ensuring compliance with regulatory requirements and pharmacopeial changes. - Addressing major challenges such as obtaining India Business Tender Certificates, test licenses, and timely FDA permissions and label artwork approvals to support the Tech transfer team. In this role, you will interact with various departments including QA, R&D, FDA coordination team, and Regulatory Affairs. Additionally, you will engage with Deputy Drug Controller CDSCO, Assistant Drug Controller, Assistant Drug Inspectors, and Drugs Inspectors. Your key decisions will involve various FDA/CDSCO applications and submissions at state FDA/CDSCO offices, as well as strategizing for key license approvals in consultation with your Reporting Manager. To excel in this role, you should possess a B.Sc./B.Pharm degree, have good coordination and communication skills, regulatory experience, and 5-10 years of experience in the pharmaceutical industry. Join us at Cipla and contribute to ensuring smooth regulatory approvals for our loan license units and fostering positive relationships with external stakeholders.,

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch v=tASq7Ld0JsQ About the Role: ValGenesis is excited to invite applications for the position of Senior Validation Engineer. In this role, you will be pivotal in ensuring the compliance and quality of our innovative software solutions tailored for the life sciences sector. As a Senior Validation Engineer, you will collaborate with diverse teams to develop comprehensive validation strategies, create and execute test cases, and maintain the project quality standard. Responsibilities - Hands on work at an individual capacity leading to deliverables - Diligently work with Product, Engineering and Testing teams to gain understanding of Product functions. - Review Product Requirements including Epics, User stories, User Requirements, Software Requirements etc. - Author test cases in OQ and PQ protocols in line with the requirements and QMS guidelines - Create realistic test cases and test data based on customer usage scenarios. - Execute test cases, create defects, create deviations, and report test results. - Peer review Test cases, test data and Test designs - Work in a highly collaborative team environment, with communication across many team members. - Good understanding of the company QMS standards - Author documents in accordance with the QMS guidelines - Lead of team of people Provide ongoing guidance, allocate work, review work - Manage the Validation of a product - be responsible for the delivery quality and timelines Requirements - BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical or related field. - Must-have 5+ years of Computer System Validation and Product Software Validation testing experience in a regulated environment. - Good knowledge of Product development life cycle - Understanding of GMP, FDA and ISO regulations - Good knowledge of testing tools and Microsoft office products - Self-motivated, willing to learn new concepts, technologies, and products quickly. - Excellent interpersonal, writing and communication skills, and troubleshooting skills. - Passionate about testing, Validation, and product quality - Able to train and help colleagues with less experience; be able to lead small projects. We're on a Mission In 2005, we disrupted the life sciences industry by introducing the world's first digital validation lifecycle management system. ValGenesis VLMS revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation - enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You'll Join Our customers" success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity's quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We're in it to win it. We're on a path to becoming the number one intelligent validation platform in the market, and we won't settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad, and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration foster creativity, a sense of community, and are critical to our future success as a company.,

You will be working in the Operations department of Pharma Solution business located in Lexington. Your role as a Manufacturing Operator will involve performing various production activities such as component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. You will report directly to the Manufacturing Supervisor. Your key responsibilities will include complying with all relevant policies and procedures, performing line clearances and cleaning/sanitization, operating and maintaining production equipment, ensuring proper ingredients and quantities of batches, executing validation protocols, maintaining records, and following Good Manufacturing Practices. You will also review SOPs, provide feedback on process improvements, troubleshoot process issues, and participate in process improvement activities. To qualify for this position, you should have a High School education or equivalent, along with at least 2 years of experience in an industrial or manufacturing environment. Experience in pharmaceutical manufacturing and/or aseptic manufacturing is preferred. You should have mechanical aptitude, the ability to follow regulatory requirements, read and interpret instructions, work effectively in a team, and demonstrate consistent attendance and reliability. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) that provides end-to-end development and manufacturing solutions across the drug life cycle. The company offers a wide range of services globally, including drug discovery, process development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. PPS also specializes in developing and manufacturing highly potent APIs, sterile fill/finish, biologics, and other pharmaceutical products. As a Manufacturing Operator at Piramal Pharma Solutions, you will play a crucial role in ensuring the quality and efficiency of production processes while adhering to regulatory standards and contributing to the growth and success of the organization.,

Role Summary: As Deputy Manager Automation (Pharma Process Validation & Documentation) , you will lead validation strategy, customer interfacing, and cross-functional coordination to ensure seamless project execution and regulatory compliance. This role demands strong technical acumen, leadership capability, and the ability to drive results across departments in a regulated pharmaceutical environment. Key Responsibilities: Lead project documentation and automation activities, ensuring timely execution and alignment with customer requirements. Manage end-to-end coordination for CRMs and KOMs preparing agendas, driving discussions, and capturing actionable outcomes. Define and implement validation strategies and master plans (VMP) in compliance with FDA, EU GMP, WHO guidelines. Oversee validation document preparation ( URS, IPD, PFDs, P&IDs, and FRS ) and ensure timely customer approvals. Supervise and mentor the validation team, ensuring training, performance tracking, and continuous improvement. Maintain compliance with Good Documentation Practices ( GDP ); manage SOP updates and audit readiness. Lead risk assessments ( FMEA ), impact analysis, and closure of deviations/ CAPAs under change control processes. Collaborate with QA, Engineering, R&D, and Project teams to ensure project and validation alignment. Monitor validation progress, analyze results, and present regular status reports to senior management. Represent validation activities during audits and regulatory inspections. Required Skills: Strong understanding of pharmaceutical validation, automation processes , and regulatory frameworks Proven leadership and team management abilities Excellent communication, presentation, and stakeholder engagement skills Strategic thinking with a focus on compliance and on-time delivery Proficiency in MS Office and technical documentation systems

Medical R&D Team Lead-Chennai-10+years-NPD Job Category: TEAM LEAD Job Type: Full Time Job Location: chennai Years of Experience: 10+ years Position Overview This is an excellent opportunity to work for the global leading company in the field of gas control equipment. The focus of this role is managing our R&D team based in Chennai who are focused on Healthcare products and covering mechanical, electrical, electronics and software disciplines. Duties & Responsibilities Managing the teams actions to delivery New Product development projects. This is an end to end responsibility of successful project delivery from gate 0 to post project audit. Manage the R&D budget, timelines, and resources effectively to achieve project goals on time and within scope Collaborate with business managers, product managers, regulatory, production, purchasing to ensure that new products and technologies meet healthcare standards, regulatory requirements, and market needs. Contribute to align the R&D strategy with the business growth goals Creative input to the NPI projects and program Point of contact for technical questions from customers/production/product management/quality & regulatory Creation, completion, and management of technical files for relevant product lines Determining test criteria, organising testing and interpretation of results Working closely with procurement to drive cost savings Working closely with production to deliver optimized production processes Metrics of success for the role Delivery of the product roadmap Project performance KPIs including, time to market, development cost, product cost, sales impact and product performance criteria Delivery of cost reduction projects Delivery on quality improvement projects Required Qualifications: Masters in Engineering Mechanical or Electronics as a minimum Minimum of 10 years of experience in R&D leadership in the healthcare or medical device industry or highly regulated industry. 3-5 years experience working in a multinational, preferably American led organization working in a Global function preferably R&D. Experience leading Engineering process (Stagegate) and systems (PLM). Preference to those with a strong understanding of healthcare regulations (FDA, CE), quality standards (ISO), and product standards (NFPA, HTM, ISO, CFR, CGA, CRN