Review and approval of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and related documents before and after production.
Perform in-process checks (IPC) during manufacturing and packaging to ensure compliance with approved specifications.
Participate in line clearance activities for production and packaging areas.
Handle change control, deviation, CAPA (Corrective and Preventive Actions).
Ensure timely preparation, review, and revision of Standard Operating Procedures (SOPs), specifications, and validation protocols/reports.
Conduct GMP audits of production, warehouse, and laboratory areas to ensure ongoing compliance.
Coordinate and support regulatory inspections and internal/external audits.
Review of equipment qualification, process validation, and cleaning validation documents.
Ensure proper document control and archival of all QA records.
Support training programs for production, QC, and other teams on quality systems and GMP practices.
Responsible for Training, Audits and records of GMP and GLP.
Ensure continuous improvement in quality systems and participate in risk assessment and root cause analysis.
Qualifications & Experience:
Education:
M.Pharm
Experience:
Minimum 5 years of relevant experience in Quality Assurance within a pharmaceutical formulation unit.
Industry Exposure:
Hands-on experience in solid oral dosage forms preferred
Skills & Competencies:
Strong knowledge of GMP, GLP, and regulatory guidelines.
Excellent documentation and review skills.
Familiarity with QMS modules: deviation, CAPA, change control, and risk management.
Proficiency in validation and qualification documentation.
Good analytical and problem-solving skills.
Effective communication and teamwork abilities.
High attention to detail and commitment to quality.
Interested candidates can share their CV on hr_india@saifendrugs.com
Job Types: Full-time, Permanent
Work Location: In person
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