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5 days ago
**Job Title**: Quality Assurance (QA) Executive - API (Bulk Drugs)
**Location**: Savli, Gujarat
**Experience**: 2 - 5 Years
**Qualification**: B.Sc / M.Sc
**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
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