QA Documentation Officer

2 days ago

Nandesari Vadodara Gujarat, India EASY HR SOLUTION Full time

**Position: QA Documentation Officer**:

- **Experience: 2 to 5 Years**:

- **Qualification: B.Sc / M.Sc**:

- **Industry: API / Pharma Manufacturing**:

- **Location: Nandesari, Vadodara**

**Roles & Responsibilities**:

- Preparation, review, issuance, and archival of GMP documents such as SOPs, BMRs, BPRs, protocols, and logbooks.
- Ensure controlled documentation practices in compliance with regulatory guidelines (cGMP, WHO, USFDA, etc.).
- Maintain and update document control systems; ensure timely revision and retrieval of documents.
- Coordinate with production, QC, and QA teams for documentation needs and change control activities.
- Handle internal and external audit documentation requests and ensure readiness.
- Maintain master document list and track issuance and retrieval status.

**Desired Skills**:

- Sound understanding of documentation practices in API manufacturing.
- Knowledge of cGMP, ICH, and regulatory guidelines.
- Proficient in MS Office tools; strong attention to detail and record-keeping.

**Job Types**: Full-time, Permanent

Pay: ₹12,868.32 - ₹34,461.69 per month

**Benefits**:

- Health insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift

Work Location: In person

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