QA Executive – API

Job Title: Quality Assurance (QA) Executive – API (Bulk Drugs)

Location: Savli, Gujarat

Experience: 2 – 5 Years

Qualification: B.Sc / M.Sc

Job Responsibilities:

• Ensure compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing.
• Preparation, review, and control of SOPs, BMRs, BPRs, change controls, deviations, and CAPAs.
• Conduct in-process checks for manufacturing and packaging activities.
• Handle investigations for deviations, OOS/OOT results, and support root cause analysis.
• Participate in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits.
• Maintain documentation for batch release, validation protocols, and quality systems.
• Ensure adherence to data integrity and good documentation practices (GDP).
• Support in qualification and validation activities (equipment, utilities, cleaning, process validation).
• Coordinate with cross-functional teams (Production, QC, R&D) for smooth operations.

Job Types: Full-time, Permanent

Pay: ₹200,000.00 - ₹350,000.00 per year

Benefits:

• Health insurance
• Provident Fund

Schedule:

• Day shift

Supplemental Pay:

• Performance bonus
• Yearly bonus

Work Location: In person