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.
Key Responsibilities
• Conduct sampling, inspection, and testing of Raw Materials (RM) as per approved procedures.
• Ensure compliance with Good Laboratory Practices (GLP) within the QC laboratory.
• Accurately record, maintain, and archive testing data and documentation.
• Maintain Raw Material retention samples and records in accordance with established procedures.
• Ensure consistency, accuracy, and compliance in all QC activities.
Requirements
• M.Sc. / BS in Chemistry or Pharm-D
• 2–4 years of relevant experience in Quality Control.
• Training in ISO/IEC 17025 and LMS awareness will be preferred.
• Strong attention to detail with a consistent and flexible approach.
• Good documentation and laboratory practices.
Key Responsibilities:
• Perform sampling, inspection, and testing of raw materials (RM).
• Prepare and maintain SOPs, Specifications, STMs, and related quality records.
• Ensure data integrity, regulatory compliance, and GLP in line with applicable international guidelines.
• Review and update STMs and specifications in accordance with current pharmacopoeial compendia.
• Support continuous improvement of QC laboratory practices and documentation.
Qualifications: M.Sc. / BS in Chemistry or Pharm-D
Experience: 4–6 years of relevant experience in Quality Control within the pharmaceutical industry.
Technical Certification: Training/certification related to ISO/IEC 17025 activities will be preferred.
Key Responsibilities:
• Prepare Product Quality Reviews (PQR) in accordance with applicable standard guidelines and regulatory requirements.
• Perform data integrity reviews of QC laboratories, warehouses, and production floor records.
• Ensure documentation and compliance activities are maintained accurately and in line with established procedures.
Education: Pharm-D / M.Sc. Chemistry
Experience: :1–2 years of relevant experience in QA Documentation, Compliance, Data Integrity, or a related pharmaceutical function.