About the role
Role Summary:We are looking for dedicated and experienced professionals to join our Quality Assurance (QA) Department as Executive / Senior Executive. The role involves supporting Validation & Qualification activities in any of the following areas:
- Process Validation
- Cleaning Validation
- Facility & Equipment Qualification
- Computer System Validation (CSV)
Key Responsibilities (based on area of expertise): Process Validation:
- Prepare and review Process Validation Protocols and Reports (PV).
- Coordinate validation batches with cross-functional teams.
- Monitor critical process parameters and ensure adherence to approved specifications.
- Perform risk assessments and gap analysis as required.
- Develop and execute cleaning validation protocols and sampling plans.
- Perform visual inspection and swab/rinse sampling for various equipment.
- Review analytical data and calculate MACO/Residue Limits.
- Maintain cleaning validation matrix and revalidation schedules.
- Support IQ, OQ, PQ of equipment, systems, and utilities as per validation master plan.
- Participate in installation, commissioning, and qualification activities.
- Ensure periodic qualification and requalification as per schedule.
- Maintain GMP-compliant records and reports for audits and inspections.
- Prepare and review URS, RA, IQ/OQ/PQ protocols for GxP systems.
- Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity principles.
- Coordinate with IT, QA, and software vendors during validation life cycle.
- Maintain validation documentation and change control records.
Candidate Profile:Qualification: B.Pharm / M.Pharm / M.Sc. (Life Sciences / Chemistry / Microbiology)Experience: 2–6 years in regulated pharmaceutical / API / sterile manufacturing environments
- Exposure to GMP, ICH, WHO, USFDA, and other regulatory guidelines is essential
- Experience in one or more of the following: Process Validation, Cleaning Validation, Equipment Qualification, or CSV
- Strong understanding of validation life cycle and risk-based approach
- Good documentation and data review skills
- Ability to coordinate with cross-functional teams (Production, QA, QC, Engineering, IT)
- Audit readiness and familiarity with regulatory expectations
- Proficiency in MS Office and documentation systems