Ipqa Officer

1 week ago

Sachin Surat Gujarat, India TNS PHARMA PVT LTD Full time

The IPQA Officer is responsible for performing in-process checks, monitoring manufacturing and packaging operations, and ensuring compliance with GMP, SOPs, and regulatory requirements. The role is critical in ensuring product quality throughout the manufacturing lifecycle.

**Key Responsibilities**:

- Perform **line clearance** and ensure readiness of area before start of batch manufacturing or packaging.
- Monitor and verify critical **in-process parameters** (e.g., weight variation, hardness, friability, disintegration, dissolution, pH, etc.).
- Review and verify **batch manufacturing records (BMR)** and **batch packaging records (BPR)** during operations.
- Ensure timely sampling of **in-process, intermediate**, and **finished products**.
- Conduct routine checks to verify **GMP compliance**, including cleanliness, gowning, and documentation practices on the shop floor.
- Participate in **process validation**, **cleaning validation**, and **equipment qualification** activities.
- Review **SOP compliance** and notify deviations, if any, during the production process.
- Report and assist in the **investigation of deviations**, **non-conformances**, and **OOS/OOT** results.
- Ensure timely **label reconciliation**, **yield calculations**, and documentation during packaging.
- Support internal and external **audits** (USFDA, WHO, EU, etc.) by ensuring real-time documentation.
- Maintain all IPQA-related records and logs as per **GDP** guidelines.

**Key Skills and Competencies**:

- Knowledge of **cGMP**, **GDP**, and **regulatory guidelines**.
- Attention to detail and accuracy in documentation.
- Strong observational and communication skills.
- Ability to handle pressure and work in a fast-paced manufacturing environment.
- Good interpersonal skills for coordination with production and QC teams.

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

Pay: ₹12,600.00 - ₹20,000.00 per month

**Benefits**:

- Flexible schedule
- Health insurance
- Internet reimbursement
- Paid sick time
- Provident Fund

Schedule:

- Day shift
- Rotational shift

Supplemental Pay:

- Yearly bonus

Work Location: In person

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