QA Executive - Pharma Industry

Greetings from Saifen Drugs India Pvt. Ltd.

We have an urgent opening for QA Executive.

Location: Naroda GIDC, Ahmedabad

Educational Qualification: M.Pharm

Key Responsibilities:

• 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