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)
Candidates with hands-on experience in one or more of these areas are encouraged to apply.
Process Validation
Key Responsibilities (based on area of expertise):
- 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.
Cleaning Validation
- 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.
Facility & Equipment Qualification
- 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.
Computer System Validation (CSV)
- 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.