Key Responsibilities
Quality Assurance Activities
- Ensure compliance with GMP, GDP, and company quality policies.
- Review and approve batch manufacturing records (BMR) and batch packing records (BPR).
- Monitor manufacturing and packing activities to ensure adherence to approved procedures.
- Perform line clearance before the start of manufacturing and packing operations.
- Conduct in-process checks and ensure compliance with quality standards.
Documentation & Compliance
- Prepare, review, issue, control, and archive SOPs, formats, and quality documents.
- Maintain document control systems and ensure proper documentation practices.
- Review logbooks, records, and reports for completeness and compliance.
- Assist in preparing quality-related reports and trend analyses.
Investigation & CAPA
- Participate in investigations related to deviations, OOS, OOT, market complaints, and non-conformances.
- Prepare and implement Corrective and Preventive Actions (CAPA).
- Follow up on CAPA effectiveness and closure.
Validation & Qualification
- Support qualification and validation activities including process validation, cleaning validation, and equipment qualification.
- Review validation protocols and reports.
- Maintain validation documentation as per regulatory requirements.
Audits & Regulatory Compliance
- Participate in internal audits and self-inspections.
- Assist during customer, regulatory, and certification audits.
- Ensure timely closure of audit observations and compliance gaps.
Training
- Conduct GMP, GDP, SOP, and quality system training for employees.
- Maintain training records and effectiveness evaluations.
Qualifications
- B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry, Biotechnology, Microbiology or related field).
Experience
- 2–5 years of experience in Quality Assurance within a pharmaceutical manufacturing company.
- Experience in tablet, capsule, liquid, ointment, or other dosage forms preferred.
Required Skills
- Knowledge of GMP, GLP, GDP, and regulatory guidelines.
- Strong documentation and report-writing skills.
- Good understanding of pharmaceutical manufacturing processes.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Good communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
Key Performance Indicators (KPIs)
- GMP compliance and audit readiness.
- Timely review and approval of quality documents.
- Effective closure of deviations, CAPA, and change controls.
- Successful completion of internal and external audits.
- Compliance with training schedules and quality objectives.
Pay: ₹15,000.00 - ₹20,000.00 per month
Benefits:
- Cell phone reimbursement
- Paid time off
- Provident Fund
Work Location: In person
