Qc

3 months ago

Cherlapally Hyderabad Telangana, India PS COLLABORATIONS Full time

**Job Title**: QC Analyst / Quality Control Officer
**Experience**: 2-6 Years
**Location**: cherlapally
**Industry**: Pharmaceuticals
**Employment Type**: Full-time

**Responsibilities**:

- **QC Testing and Analysis**:

- Perform routine quality control tests on raw materials, intermediates, and finished pharmaceutical products using **HPLC** and **GC**.
- Analyze and interpret chromatographic data to ensure product quality and compliance with regulatory standards.
- **Method Development and Validation**:

- Assist in the development, validation, and transfer of analytical methods using **HPLC** and **GC** for new drug substances and products.
- Ensure method suitability through testing, documentation, and troubleshooting.
- **Compliance with cGMP/GLP**:

- Ensure all QC activities comply with **cGMP** (Current Good Manufacturing Practices), **GLP** (Good Laboratory Practices), and company-specific SOPs.
- Conduct testing in line with regulatory standards (FDA, EMA, ICH) and follow strict documentation practices.
- **Instrument Operation & Maintenance**:

- Operate, calibrate, and maintain **HPLC** and **GC** systems, ensuring they are in optimal working condition.
- Troubleshoot technical issues with chromatographic systems and ensure timely resolution.
- **Data Review and Reporting**:

- Record and review test results, ensuring accuracy and completeness in documentation and compliance with regulatory standards.
- Prepare detailed reports on results, OOS (Out of Specification) investigations, and CAPA (Corrective and Preventive Actions) documentation.
- **Stability Testing**:

- Conduct stability testing on pharmaceutical products to determine their shelf life and degradation under various conditions, using **HPLC** and **GC** methods.
- **Regulatory Compliance**:

- Collaborate with regulatory teams to ensure compliance with local and international regulations (FDA, WHO, EMA, etc.).
- Assist with audits and inspections by regulatory bodies and ensure the QC laboratory is audit-ready at all times.
- **Quality Assurance Collaboration**:

- Work closely with Quality Assurance (QA) teams to ensure smooth operations and the resolution of quality-related issues.
- Support QA teams in investigations related to deviations, batch failures, and complaints.
- **Training and Development**:

- Train junior analysts and laboratory technicians on **HPLC**, **GC** operation, and good documentation practices.
- Stay updated on the latest advancements in analytical technologies and regulatory guidelines.

**Key Requirements**:

- **Education**: Bachelor’s or Master’s degree in **Pharmaceutical Sciences**, **Chemistry**, **Biochemistry**, or a related field.
- **Experience**: 2-6 years of experience in **pharmaceutical quality control**, with strong expertise in **HPLC** and **GC** techniques.
- In-depth knowledge of **cGMP**, **GLP**, and regulatory requirements for the pharmaceutical industry (FDA, EMA, ICH guidelines).
- Hands-on experience with method development, validation, and troubleshooting of analytical methods for pharmaceuticals.
- Familiarity with software like **Empower** or **Chromeleon** for HPLC/GC data analysis.
- Strong documentation and communication skills, with the ability to work in a highly regulated environment.

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

Pay: Up to ₹500,000.00 per year

Schedule:

- Day shift
- Fixed shift

Work Location: In person

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