Executive- Quality Control

2 days ago

Bharuch, India Farmson Basic Drugs Pvt Ltd Full time

**Job Title**: Quality Control Executive - Finished Product (Chemical Testing)

**Department**: Quality Control (QC)
**Location**: [Insert Location]
**Reports to**: QC Manager / Quality Head
**Experience Required**: 2-5 years in pharmaceutical/chemical industry
**Qualification**: B.Sc. / M.Sc. (Chemistry), B.Pharm / M.Pharm

**Job Purpose**:
Responsible for sampling and chemical analysis of finished pharmaceutical products, ensuring compliance with standard operating procedures (SOPs), regulatory standards (ICH), and internal quality specifications using techniques such as HPLC, UHPLC, GC, and wet chemistry.

**Key Responsibilities:1. Sampling & Testing**
- Perform **sampling of finished products** as per approved SOPs.
- Conduct **chemical analysis** using validated analytical methods (wet chemistry and instrumental methods like HPLC, UHPLC, GC).
- Ensure all tests are conducted in accordance with **Analytical Data Sheets** and **test methods**.

**2. Documentation & Compliance**
- Prepare and maintain test records, **COAs (Certificate of Analysis)**, **WRS (Working Reference Standards)** logbooks, and **Analytical Data Sheets**.
- Maintain raw data and ensure timely review and approval of results.
- Adhere to **ICH Q2/Q6** guidelines for method validation and product specifications.

**3. Investigation & Reporting**
- Handle **OOS (Out of Specification)** and **OOC (Out of Trend)** results, including root cause analysis, CAPA implementation, and documentation.
- Participate in **Deviation, Change Control (DC), and Corrective/Preventive Actions (CAPA)** processes.

**4. Instrument Operation & Calibration**
- Operate and troubleshoot **HPLC, UHPLC, GC**, UV, and other analytical instruments.
- Ensure instruments are calibrated and maintained as per AMC (Annual Maintenance Contract) schedules.

**5. Stability & Regulatory Compliance**
- Perform **stability studies** on finished products as per **ICH guidelines** and ensure timely reporting.
- Contribute to **CSR (Comparative Study Report)** and **regulatory documentation** when required.

**6. Review & Audit**
- Conduct peer reviews of analytical documents.
- Assist during internal and external audits (e.g., USFDA, WHO, MHRA).
- Ensure GMP and GLP compliance in the QC lab.

**Required Skills**:

- In-depth knowledge of analytical techniques (HPLC, GC, wet chemistry)
- Understanding of **ICH guidelines**, **GMP/GLP**, **OOS/OOC handling**:

- Good documentation practices and data integrity awareness
- Proficient in analytical software (Empower, LabSolutions, Chromeleon preferred)

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

Pay: ₹300,000.00 - ₹600,000.00 per year

**Benefits**:

- Food provided
- Health insurance
- Provident Fund

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