Manager

10–16 years of experience in Computer System Validation (CSV) within a regulated pharmaceutical environment, with in-depth knowledge of 21 CFR Part 11, GAMP 5, Annex 11, Data Integrity, and computerized system validation and compliance requirements.

Lead and manage CSV activities for ERP, LIMS, QMS, LMS, SAP, laboratory and manufacturing computerized systems, ensuring regulatory compliance, business continuity, and successful execution of validation projects through cross-functional collaboration, audit readiness, and lifecycle management of computerized systems.

Responsibilities :

• Experience in validation of ERP, LIMS, QMS, LMS, QMS, SAP, Laboratory Systems, Manufacturing Systems, and Infrastructure Qualification.
• Lead and manage CSV activities including URS, Risk Assessment, IQ/OQ/PQ, Validation Protocols, and Reports.
• Collaborate with QA, IT, Engineering, Manufacturing, and Regulatory teams to ensure compliance and business continuity.
• Experience in handling regulatory inspections and audits by USFDA, MHRA, EU-GMP, and other global authorities.
• Strong project management, stakeholder management, and vendor coordination skills.
• Hands-on experience with change control, incident management, CAPA, and periodic review processes.
• Working knowledge of SAP/ERP systems, IT infrastructure, and pharmaceutical automation platforms.
• Ability to lead multiple projects in a fast-paced, compliance-driven environment.

Qualification : Any Graduation / Engineering in IT, Computer Science or relevant discipline

Required Skills: 10–16 years of relevant experience in IT-CSV within the pharmaceutical industry.

Preferred Skills : Experience in USFDA/EU-approved pharmaceutical manufacturing facilities and exposure to digital transformation and computerized quality systems.