Job Title: Senior Quality Chemist / Assistant Manager – Quality Control (QC)
We are seeking an experienced and motivated Senior Quality Chemist / Assistant Manager – Quality Control to join our pharmaceutical manufacturing team. The ideal candidate will have strong hands-on experience in analytical testing, particularly HPLC and Dissolution, with exposure to pellet dosage forms. The candidate will be responsible for ensuring product quality through laboratory testing, method compliance, data integrity, and team coordination while adhering to cGMP and regulatory requirements.
Key Responsibilities
- Perform and supervise analysis using HPLC, Dissolution, UV-Visible Spectrophotometer, and other analytical instruments.
- Conduct routine analysis of raw materials, in-process samples, finished products, stability samples, and cleaning validation samples.
- Review analytical data, chromatograms, laboratory records, and Certificates of Analysis (COAs).
- Ensure compliance with cGMP, GLP, data integrity, and company SOPs.
- Handle OOS (Out of Specification), OOT (Out of Trend), deviations, CAPA, and change controls.
- Perform instrument calibration, qualification, troubleshooting, and preventive maintenance.
- Support analytical method verification, method transfer, and validation activities.
- Coordinate laboratory activities and ensure timely release of materials and products.
- Guide and train QC chemists and analysts to improve laboratory performance.
- Participate in internal, customer, and regulatory audits.
- Ensure laboratory safety and maintain accurate documentation.
Required Qualifications
- M.Sc. in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or B.Pharm/M.Pharm.
- 6–10+ years of experience in a pharmaceutical Quality Control laboratory.
- Strong expertise in HPLC and Dissolution testing.
- Experience with pellet formulations is highly preferred.
- Good knowledge of cGMP, GLP, ICH guidelines, FDA, EU GMP, and data integrity requirements.
- Experience in handling OOS investigations, laboratory documentation, and audit readiness.
- Leadership, communication, and problem-solving skills.
Preferred Skills
- Knowledge of stability studies and analytical method validation.
- Ability to manage laboratory teams and prioritize multiple assignments.
- Strong attention to detail and commitment to quality.
Experience
4–10+ years
Industry
Pharmaceutical Manufacturing
Location
Cherlapally, Hyderabad
Salary
Competitive salary, based on experience and qualifications.
Pay: ₹30,000.00 - ₹70,000.00 per month
Work Location: In person
