Qc Chemist, Glp

**Job Description: QC Chemist (GLP) - Pharmaceutical Manufacturing Unit**

**Position Title**: QC Chemist (GLP)

**Department**: Quality Control

**Location**: Bhagwanpur, Roorkee.

**Reports to**: QC Manager / Senior QC Chemist

**Job Purpose**:
The QC Chemist (GLP) is responsible for ensuring the quality and safety of pharmaceutical products through rigorous testing, analysis, and compliance with Good Laboratory Practices (GLP) in a pharmaceutical manufacturing environment. The role ensures that all products meet internal quality standards and regulatory requirements before reaching the market.

**Key Responsibilities**:

- **Analytical Testing**:

- Perform chemical, physical, and microbiological testing of raw materials, in-process samples, finished products, and stability studies.
- Conduct instrument-based testing using techniques such as HPLC, GC, FTIR, UV-Vis, and others.
- Ensure all tests are conducted according to approved SOPs and testing protocols.
- **Compliance with GLP and Regulatory Guidelines**:

- Maintain compliance with GLP, GMP (Good Manufacturing Practices), and other applicable regulatory standards (FDA, EMA, ICH).
- Ensure proper documentation and record-keeping of all testing results.
- Conduct regular reviews and audits of laboratory practices to ensure GLP compliance.
- Report and investigate deviations or non-conformance, and implement corrective actions.
- **Laboratory Equipment Maintenance**:

- Ensure calibration and maintenance of laboratory instruments and equipment.
- Troubleshoot and repair minor equipment malfunctions.
- Coordinate with the maintenance department for major repairs or upgrades.
- **Documentation & Reporting**:

- Prepare and maintain accurate records of all testing results, including raw data, analysis reports, and certificates of analysis (COA).
- Write and review test protocols, methods, and reports to ensure compliance and accuracy.
- Ensure data integrity, confidentiality, and proper storage of all records.
- **Sample Management**:

- Receive, label, and track raw material and product samples.
- Ensure that samples are retained as per regulatory guidelines.
- **Training and SOP Adherence**:

- Participate in training sessions on GLP, GMP, and any new testing methodologies.
- Ensure adherence to SOPs and GLP guidelines for all laboratory activities.
- Assist in the preparation and review of new SOPs and methods.
- **Collaboration & Communication**:

- Work closely with other departments such as production, R&D, and regulatory affairs to ensure smooth workflow and address quality concerns.
- Communicate results and quality issues to senior management.

**Key Requirements**:

- **Education**: Bachelor’s/Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
- **Experience**: 3+ years of experience in a pharmaceutical Quality Control (QC) laboratory, with a focus on GLP, preferably in a manufacturing environment.
- **Technical Skills**:

- Proficiency in analytical instrumentation (e.g., HPLC, GC, UV, FTIR, etc.).
- Knowledge of GLP, GMP, and other relevant regulatory requirements.
- Familiarity with software for data analysis and reporting (e.g., LIMS, MS Office).

Pay: ₹20,000.00 - ₹35,000.00 per month

**Benefits**:

- Internet reimbursement
- Leave encashment

Schedule:

- Day shift
- Morning shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

**Education**:

- Bachelor's (required)

**Experience**:

- total work: 3 years (required)

Work Location: In person