Quality Control Officer

1 week ago

Sachin Surat Gujarat, India Trident Lifeline Pvt. Ltd. Full time

**Job Summary**:
The QC Officer is responsible for sampling, analyzing, and validating raw materials, packaging materials, in-process samples, finished products, and stability samples to ensure compliance with GMP, regulatory standards, and company SOPs.

**Key Responsibilities**:

- **Sample Collection & Testing**:

- Perform sampling and testing of raw materials, packing materials, and finished products as per SOPs.
- Conduct chemical and physical analysis using instruments such as HPLC, UV, FTIR, GC, etc.
- **Documentation & Reporting**:

- Maintain proper documentation (records, logbooks, and reports) in compliance with Good Documentation Practices (GDP).
- Prepare Certificate of Analysis (CoA) and maintain testing records.
- **Stability Studies**:

- Conduct stability sample analysis as per schedule and regulatory requirements.
- **In-Process Quality Checks**:

- Support production by performing in-process quality control checks.
- **Calibration & Maintenance**:

- Ensure calibration and preventive maintenance of QC instruments.
- Report any instrument malfunction or deviation immediately.
- **Compliance & Audit Readiness**:

- Follow cGMP and safety protocols strictly.
- Participate in internal and external audits (USFDA, WHO, EU-GMP, etc.) and support audit documentation.
- **Deviation, OOS & CAPA Handling**:

- Support investigations in case of OOS (Out of Specification), deviations, and implement CAPA.

**Key Skills & Competencies**:

- Good understanding of cGMP, ICH, and regulatory guidelines.
- Proficiency in analytical instruments (HPLC, GC, UV, etc.).
- Strong documentation and data integrity practices.
- Analytical thinking and attention to detail.
- Effective communication and teamwork.

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

Pay: ₹15,000.00 - ₹25,000.00 per year

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental Pay:

- Performance bonus

Work Location: In person

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