Quality Assurance Executive

Greetings from Saifen Drugs India Pvt. Ltd.

We have an urgent opening for a QA Executive.

Location: Naroda, Ahmedabad.

Job Summary:

We are looking for an experienced Quality Assurance Executive with an M.Pharm and at least 5 years of experience in the pharmaceutical industry (preferably in solid oral dosage manufacturing). The candidate will be responsible for ensuring compliance with cGMP, regulatory, and company quality standards, maintaining documentation accuracy, and supporting continuous quality improvement initiatives.

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.
• Candidate should be an approved chemist.

Interested candidate can share their CV on hr_india@saifendrugs.com or WhatsApp on 7600235820.