Quality Assurance – Validation and Process Validation (Parenteral Operations)
QA – Validation and Process Validation (Parenteral Operations)
- Position: Executive / Sr. Executive / Assistant Manager
- Experience: 3–12 years
- Qualification: B.Pharm / M.Pharm / M.Sc / B.E./B.Tech (Chemical, Biotechnology, Instrumentation)
Industry: Sterile/Parenteral/Injectable Manufacturing
QA Validation – Key Responsibilities
- Review and approve validation protocols and reports.
- Ensure compliance with cGMP and regulatory requirements.
- Oversight of equipment, utility, facility, and computerized system qualification.
- Review cleaning validation and sterilization validation activities.
- Approve aseptic process simulation (Media Fill) studies.
- Evaluate validation impact through change control.
- Review validation-related deviations and CAPAs.
- Ensure periodic requalification and revalidation activities.
- Maintain Validation Master Plan (VMP).
- Support regulatory inspections and customer audits.
QA Process Validation – Key Responsibilities
- Review and approve Process Validation (PV) protocols and reports.
- Ensure validation batches are executed as per approved protocols.
- Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
- Review batch manufacturing and validation documentation.
- Provide QA oversight during PPQ/validation batch execution.
- Review process validation deviations and investigations.
- Ensure continued process verification (CPV) and trend monitoring.
- Review hold-time validation studies.
- Support technology transfer and product lifecycle management.
- Ensure the validated state of manufacturing processes is maintained.
- Participate in Annual Product Quality Review (APQR/PQR).
- Support regulatory inspections and audit readiness.
Interested candidate can share cv on : Vishal.Raval@zyduslife.com
IPQA Officer/ Executive
JOB Responsibilities:
- Perform line clearance before batch initiation and after batch completion.
- Monitor manufacturing and packaging activities as per approved BMR/BPR and SOPs.
- Verify dispensing, granulation, compression, coating, capsule filling, blistering, and packing activities.
- Conduct in-process checks and ensure compliance with established specifications.
- Review and verify manufacturing records, logbooks, and batch documentation.
Interested candidates can apply on this job or directly share their CVs @noor.m.judge@zyduslife.com