5 Gamp 5 Jobs

JOB OVERVIEW: To perform and author Computer System Validation activities of GxP Computerized as per defined processes at Corporate IT and across Piramal Pharma sites. KEY STAKEHOLDERS: INTERNAL Business Site / Corporate functions IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) KEY STAKEHOLDERS: EXTERNAL IT Vendors IT Contractors/Consultants REPORTING STRUCTURE: Will report to Chief Manager- IT CSV EXPERIENCE: Candidate with 3- 6 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity Work experience in Pharmaceutical Sector will be desirable SKILLS AND COMPETENCIES Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal written) KEY ROLES RESPONSIBILITIES To have thorough understanding, practical approaches for Computer system validation (CSV) of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To create infrastructure ((Network, Servers, Cloud, Database) qualification documentation. To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms. To perform Root cause analysis and define CAPA based on QMS documents review. To perform periodic and audit trail review of computerized systems as per defined frequency. To support the initiatives undertaken by Quality eCompliance and CSV team across the Corporate/PEL sites. Perform IT Supplier assessment and ensure compliance of audit observations. To liaise with Site ITC SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT CSV teams (Corporate Site) for CSV, Data Integrity and Regulatory Compliance activities. Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) Ability to represent during regulatory audits and can able to perform Corporate DI Audits of sites. To work along with CSV Project Manager to ensure project timelines are met. Knowledge Required:- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC, QA, IT, CSV etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Good Knowledge on Computer Software Assurance Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes. (Plus) Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must) QUALIFICATION: Graduate in Science/Pharmacy/Engineering Post Graduation Science/MBA (Desirable)

Key Responsibilities: What are we looking for Analysts Consultants Senior Consultants We are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellence Our analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skills We are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation Risk Management and Audits2 14 years of professional experience in Life Sciences industry working for a consulting services organization and or industry experience Understanding of key pharmaceutical compliance regulations like Computerized System Validation 21 CFR part 11 GxP GAMP 5 SOX IT Data Privacy Data Integrity and Information Security Subject matter expertise in areas such as Quality Management document management and Change Management Establish implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements Knowledge of Risk management perform root cause analysis on trends and address deviations via preventive detective and corrective measures Experienced in Validation of SAP S4 HANA projects Knowledge and hands on experience conducting periodic or control maturity assessment and Audits Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry Successful track record using Lean Agile approaches to validate assets Proven ability in handling multiple large projects respond quickly to changing situations in complex environments Preferable IT background to understand larger impact of architecture technical complexities on the program Experienced in leading strategic and tactical discussions with Senior stakeholders MBA and or Advanced degree MS MPH PharmD and or PhD is preferred Preferred Skills: Technology->Life Sciences->Regulatory Systems

Job Description: A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc and build POCs You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you Key Responsibilities: Key components of the responsibilities are as mentioned below but not limited to 6 yrs of Professional experience and strong knowledge with real time experience in IT Quality Compliance Computer System Validation Software Testing System Implementation in the Life Sciences industry Leads the effort to manage and or maintains validation of the GxP computerized systems Create Validation Plan Validation Report and Reviews validation documents such as URS FS FRA DD IQ OQ PQ s TRM Assure compliance with GxP GMP GCP GLP privacy requirements Develops and maintains IT GxP compliance documentation Ensure GxP Computerized Systems are validated as per GAMP 5 requirements Stakeholder management and good executor with required communication Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation Qualification o Risk management o Handling of defects Deviations o Investigations o CAPA Handling o Test Management Compliance Candidate must have understating on latest regulations i e 21CFR Part 11 EU annex 11 and Guidelines e g GAMP5 guide Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i e standalone enterprise etc Technical Requirements: Hands on experience on testing tools like HP ALM Kneat and SNOW Experience to MES QMS Trackwise Lab solutions i e LIMS Empower CDS Chromeleon Business Analytics Middle wares etc will be an advantage OT System Qualification Radio ligand Therapy or critical dosage forms will be a plus PAS DCS Qualification ISA95 High level of understanding OT Security will be a plus Standalone Systems Qualifications PAS DCS Integrated with Manufacturing Equipment qualification Preferred Skills: LS Domain->Computer System Validation (CSV)

Job Description: Proffered Profile: Bachelors degree (BE/B tech) with 3-5 years of experience in IT QMS Compliance Specialist ensures alignment of all IT systems, processes, and documentation with internal Quality Management Systems (QMS) and applicable regulatory standards such as GxP, ISO 9001, 21 CFR Part 11, and EU Annex 11. This role plays a key part in audit preparedness, deviation management, and maintaining consistent quality across IT operations and projects. Key Responsibilities: Develop, implement, and maintain IT quality policies, SOPs, and work instructions in accordance with QMS. Ensure compliance of IT systems with relevant regulatory requirements (GxP, 21 CFR Part 11, GDPR, etc.). Collaborate with QA, Validation, and Business teams for development, qualification, and maintenance of IT systems as per CSV and QMS guidelines. Manage QMS elements such as deviations, CAPAs, change controls, audit trails, and periodic reviews. Participate in internal/external audits; coordinate documentation, evidence, and responses. Conduct IT quality risk assessments and support necessary remediation. Maintain accurate records of compliance activities, including SOP training and validation documentation. Deliver training programs to IT teams on QMS processes and compliance awareness. Support full lifecycle management of computerized systems (planning, validation, operation, retirement). Assist with vendor qualification and assessments for IT-related services. Required Skills and Qualifications: 3 - 5 years in IT compliance/QA/validation in a regulated industry Working knowledge of ISO 9001, GAMP 5, 21 CFR Part 11, EU Annex 11 Familiar with LIMS, ERP, MES, DMS systems Strong documentation and analytical skills Good understanding of ALCOA+ and data integrity Preferred Certifications: ISO Lead Auditor, Six Sigma, or other Quality Management certifications

Let's do this. Let's change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated. Roles & Responsibilities: Develop comprehensive test plans and strategies based on project specifications and requirements. Perform manual and automated testing of software applications, including functional, regression, and performance testing. Document and report defects identified during testing and collaborate with development teams for resolution. Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance. Validate test scenarios against feature acceptance criteria and customer expectations. Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability. Identify opportunities to enhance testing efficiency and minimize manual efforts. Evaluate and adopt tools and technologies to improve automation capabilities. Keep validation documentation updated and aligned with GxP standards. Ensure strict adherence to change management processes for validated systems. Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP. Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms. What we expect of you: We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master's degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor's degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience Experienced in GxP validation process Have 4-5 years of experience in the Pharmaceutical Industry Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience in writing requirements for the development of a modern web application Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11 Proficiency in automation tools, data systems, and validation software Preferred Qualifications: Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes Knowledge of the Disclose application from Citeline and docuBridge from Lorenz Demonstrated expertise in a scientific domain area and related technology needs Understanding of scientific software systems strategy, governance, and infrastructure Familiarity with low-code, no-code test automation software Technical thought leadership Able to communicate technical or complex subject matters in business terms Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills