3 Gamp5 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)

Position Summary This role offers a compelling opportunity to work with leading clients in the life sciences and healthcare space, supporting regulatory compliance, governance, and quality system validation initiatives. Youll be part of a dynamic team, driving innovation and ensuring adherence to global standards in regulated environments. Key Responsibilities Regulatory Compliance: Identify and manage regulatory risks to support clients in compliance, governance, and control frameworks. Project Leadership: Lead and coordinate cross-functional teams for new product development, system validations, and quality assurance activities. Process Improvement: Assist clients in developing strategies for process improvements that align with the needs of the quality organization. Validation Expertise: Author validation strategies, protocols, and summary reports. Lead end-to-end computerized system validation (CSV) activities (experience is mandatory ). Plan, manage, and execute IQ, OQ, and PQ activities in accordance with cGMP. Cross-Functional Coordination: Collaborate with R&D, Engineering, Software Development, IT, Manufacturing, and QA teams for successful project execution and training. Documentation & Review: Review and approve validation lifecycle documentation. Identify and resolve validation deviations with appropriate CAPAs. Provide quality review of change requests related to processes, IT infrastructure, equipment, and systems. Project Governance: Manage project updates, escalation closures, and strategic decisions with senior management. Training & Knowledge Transfer: Initiate workshops and training sessions to build competence across teams. About the Team Deloittes Regulatory & Operational Risk Life Sciences & Healthcare (R&OR LSHC) team provides specialized validation services addressing regulatory requirements (GxP, Part 11) and governance controls across people, processes, and technology. Our mission is to help organizations evolve through disruption with strategic resilience and compliance excellence. Required Qualifications & Experience Bachelors degree (or equivalent) 2.5–5 years of experience in the pharmaceutical or medical device industry Strong understanding of quality systems and regulatory compliance Hands-on experience with: Computer system validation (CSV) Software development lifecycle methodologies (GAMP5, Agile, Waterfall) Demonstrated project management skills on medium to large-scale projects Proficiency in identifying risks, analyzing problems, and implementing effective solutions Strong communication and presentation abilities Team-oriented mindset with a collaborative approach Preferred Qualifications Master’s degree in a relevant discipline In-depth knowledge of pharma and medical device quality systems Understanding of design controls , manufacturing processes , and risk management principles

Roles and Responsibilities Conduct CSV activities such as risk assessment, gap analysis, and validation planning. Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11. Ensure compliance with EU Annexure 11 requirements for software validation. Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems. Develop test scripts and execute tests using V-model approach. Preparation, Execution, Compilation and approval of below documents (Not limited to) 1) User requirement specifications 2) Validation Plan 3) GxP Assessment 4) System Design Specification 5) Risk Assessment 6) Network (Infra) Qualification 7) Installation Qualification protocol 8) Operational Qualification 9) Performance Qualification 10) Traceability matrix 11) Validation summary report