Senior QC- Formulation

Job Title: Senior QC Executive – Formulations

Department: Senior Quality Control (QC)
Location: Cherlapally
Experience: 4–8 years (in QC – Formulations)
Qualification: B.Pharm / M.Pharm / M.Sc (Analytical Chemistry preferred)
Industry: Pharmaceutical Formulations (Pellets)

Job Summary:

We are looking for a skilled and experienced Senior QC Executive – Formulations to manage analytical testing and validation activities in the Quality Control department. The candidate should have hands-on experience in HPLC, UV spectrophotometry, analytical method validation, and routine quality control testing for pharmaceutical formulations.

Key Responsibilities:1. Analytical Operations

• Perform routine and stability analysis of finished products and raw materials using HPLC, UV, and other analytical instruments.
• Handle HPLC instrument calibration, troubleshooting, and maintenance.
• Prepare and review analytical test reports, chromatograms, and related documentation.
• Conduct assay, dissolution, related substances, and content uniformity tests.

2. Method Development & Validation

• Support analytical method development, transfer, and validation as per ICH guidelines.
• Prepare and execute method validation protocols and reports.
• Evaluate analytical data for accuracy, precision, and compliance with specifications.

3. Documentation & Compliance

• Prepare and review SOPs, STPs, and specifications related to QC activities.
• Ensure compliance with cGMP, GLP, and data integrity requirements.
• Maintain proper laboratory documentation and instrument logbooks.
• Participate in OOS/OOT investigations and implement CAPA where necessary.

4. Instrument Handling & Calibration

• Operate and maintain analytical instruments like HPLC, UV, FTIR, pH meter, dissolution tester, balance, and KF titrator.
• Ensure timely instrument qualification (IQ/OQ/PQ) and calibration activities.
• Coordinate with service engineers for preventive maintenance and troubleshooting.

5. Quality System & Audits

• Participate in internal and external audits (regulatory / customer).
• Ensure adherence to laboratory safety and quality system requirements.
• Train junior analysts on analytical techniques and documentation practices.

Required Skills & Competencies:

• Hands-on experience in HPLC operation and method validation (Empower / Chromeleon preferred).
• Strong understanding of pharmaceutical formulation analysis and regulatory guidelines (ICH, WHO, USFDA, MHRA).
• Excellent knowledge of UV spectrophotometry and other QC instruments.
• Good communication, analytical, and documentation skills.
• Ability to work independently and manage multiple analytical tasks.

Job Type: Full-time

Pay: ₹20,000.00 - ₹60,000.00 per month

Work Location: In person