QA Executive

6 days ago

Vadodara Gujarat, India Easy HR Solution Full time

**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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