Job Title: QA Executive / Officer – IPQA, Documentation & BMR
Location: Kala Amb, Himachal Pradesh
Industry: API Pharmaceutical Manufacturing Plant
Qualification:
- B.Pharm / M.Pharm / M.Sc. (Chemistry, Microbiology or relevant Life ScienceX Experience:
- 2–5 Years
- Experience in an API Pharmaceutical Manufacturing Plant preferred.
Job Description (JD)
We are looking for a detail-oriented QA Executive/Officer to support IPQA, Documentation, and BMR review activities in our API Pharmaceutical Manufacturing Plant. The candidate will be responsible for ensuring GMP compliance, maintaining documentation accuracy, and monitoring manufacturing processes to meet quality standards.
Key Responsibilities
- Perform In-Process Quality Assurance (IPQA) activities during manufacturing and packing operations.
- Review Batch Manufacturing Records (BMR) and Batch Packing Records (where applicable) for accuracy and GMP compliance.
- Prepare, review, and control GMP documentation including SOPs, formats, logbooks, protocols, and reports.
- Conduct line clearance before production activities and verify compliance with approved procedures.
- Monitor critical manufacturing processes and ensure adherence to approved BMRs and SOPs.
- Issue, reconcile, and archive controlled documents.
- Report and document deviations, incidents, and non-conformances.
- Coordinate with Production, QC, and Engineering departments to ensure smooth quality compliance.
- Participate in investigations, CAPA implementation, change control, and internal audits.
- Ensure compliance with cGMP, data integrity, and regulatory requirements.
- Support self-inspections, customer audits, and regulatory inspections.
Key Requirements
- B.Pharm / M.Pharm / M.Sc. qualification.
- 2–5 years of QA experience in an API Pharmaceutical Manufacturing Plant.
- Hands-on experience in IPQA, Documentation, and BMR review.
- Good understanding of cGMP, GDP, ALCOA+ principles, and data integrity.
- Knowledge of SOP preparation, document control, deviation, CAPA, and change control.
- Familiarity with GMP documentation practices and regulatory expectations.
- Strong attention to detail and documentation skills.
- Good communication, analytical, and problem-solving abilities.
- Willingness to work in shifts if required.
Pay: Up to ₹40,000.00 per month
Benefits:
- Health insurance
- Paid sick time
- Paid time off
Work Location: In person
