Skip to Content

Deputy Manager Validation & Qualification

PLANT - F319 TSCL / Quality Operations Permanent
Apply Now

Key Responsibilities

  • Plan and execute Computer System Validation (CSV) documentation, including Validation Plans, URS, FS, DS, Risk Assessments, IQ, OQ, PQ Protocols and Validation Summary Reports.
  • Validate GxP computerized systems in accordance with GAMP 5, 21 CFR Part 11, EU Annex 11 and applicable regulatory requirements.
  • Conduct periodic reviews, system change assessments and revalidation activities.
  • Evaluate software changes and upgrades through Change Control.
  • Coordinate with IT, software vendors and system owners throughout system implementation and qualification.
  • Develop Cleaning Validation Master Plans, protocols and reports.
  • Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ and qualification reports.
  • Qualify pharmaceutical manufacturing facilities, cleanrooms, HVAC systems, purified water systems, compressed air, nitrogen, steam and other critical utilities.
  • Collaborate with Production, Engineering, QC, QA, IT and external vendors to ensure successful validation and qualification activities.

Educational Qualifications

  • BE/BS – Computer Science / Software Engineering / Computer Systems Engineering
  • Pharm-D
  • M.Sc. Chemistry / Applied Chemistry

Technical Requirements

  • 6–8 years of hands-on experience in Computer System Validation (CSV) within a pharmaceutical or regulated manufacturing environment.
  • Strong knowledge of GAMP 5, CSV lifecycle and regulatory expectations.
  • Hands-on experience with SAP/ERP, LIMS or other GxP computerized systems.
  • Sound knowledge of GAMP 5 categories, URS, Risk Assessment, DQ/IQ/OQ/PQ, 21 CFR Part 11, EU Annex 11 and Data Integrity (ALCOA+).
  • Strong problem-solving, communication, coordination and team management skills.
  • CSV certification/training will be an added advantage.

Why Join Us?

Be part of a dynamic pharmaceutical environment where you can contribute to regulatory compliance, digital systems validation and qualification of critical pharmaceutical facilities and utilities.

Interested candidates are encouraged to apply and become part of our team.