Ipqa Officer

3 days ago

Makarpura Vadodara Gujarat, India SHAIMIL LABORATORIES Full time

**Job Title**: IPQA Officer / Executive

**Department**: Quality Assurance
**Location**: MAKARPURA GIDC (Formulation Company)
**Reporting To**: IPQA Manager / QA Head

**Job Purpose**:
To ensure in-process quality checks and compliance during manufacturing and packaging operations in accordance with cGMP, regulatory guidelines, and company SOPs. IPQA ensures that quality is built into the product during manufacturing and packaging processes.

**Key Responsibilities:1. In-Process Checks**:

- Perform in-process checks during manufacturing and packaging (e.g., weight variation, hardness, friability, disintegration, etc. for tablets).
- Monitor critical process parameters (CPP) and ensure adherence to batch manufacturing records (BMR) and batch packaging records (BPR).
- Line clearance at every stage (dispensing, granulation, compression, coating, primary and secondary packaging).
- Check cleanliness and status labeling of equipment and manufacturing areas.

**2. Documentation and Compliance**:

- Review and ensure correctness of in-process documents like BMRs and BPRs.
- Real-time documentation of deviations, incidents, and change controls.
- Ensure compliance with GMP, GDP, and company policies.

**3. Sampling and Testing**:

- Perform sampling of in-process materials, intermediates, and finished products as per SOP.
- Collect environmental and line clearance samples, if applicable.

**4. Deviation and Incident Handling**:

- Identify and report process deviations, incidents, or non-conformities.
- Support investigation and implementation of CAPA (Corrective and Preventive Actions).

**5. Training and Audit Support**:

- Provide on-the-job GMP training to operators and production personnel.
- Support internal/external audits (regulatory and customer).
- Ensure readiness of manufacturing area for audit and inspections.

**Key Skills and Competencies**:

- Knowledge of GMP, GDP, and regulatory compliance.
- Good documentation practices.
- Attention to detail and problem-solving attitude.
- Basic knowledge of instruments like pH meter, balance, hardness tester, etc.
- Communication and coordination skills.

**Qualifications and Experience**:

- **Education**: B.Pharm / M.Pharm / B.Sc / M.Sc in relevant field.
- **Experience**: 1-5 years of experience in IPQA in a pharmaceutical formulation/API manufacturing unit.

Pay: ₹9,605.87 - ₹25,000.00 per month

**Benefits**:

- Paid sick time
- Provident Fund

Schedule:

- Day shift
- Morning shift
- Night shift
- Rotational shift
- Weekend availability

Supplemental Pay:

- Overtime pay
- Yearly bonus

Work Location: In person

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