Job Description

Senior Quality Control Officer is responsible for overseeing and performing quality control activities to ensure that all raw materials, in-process samples, and finished pharmaceutical products meet the required quality standards and regulatory specifications. The role involves analytical testing, documentation, instrument calibration, and compliance with

Good Laboratory Practices (GLP)

and

Good Manufacturing Practices (GMP)

.

Key Responsibilities:

Conduct analysis of raw materials, in-process, and finished products using approved test methods and specifications. Review and verify analytical data, results, and laboratory records for accuracy and compliance. Supervise junior QC analysts and provide technical support and training as required. Ensure timely calibration, maintenance, and qualification of laboratory instruments (e.g., HPLC, GC, UV, FTIR, Dissolution tester). Prepare and review Standard Operating Procedures (SOPs), test reports, and analytical method validation documents. Participate in method validation, stability studies, and process validation activities. Ensure adherence to GLP, GMP, and regulatory standards (WHO, USFDA, MHRA, EU-GMP, etc.). Handle deviations, out-of-specification (OOS), and out-of-trend (OOT) results in coordination with QA and Production teams. Maintain good documentation practices and ensure data integrity. Support internal and external audits and implement corrective and preventive actions (CAPA). Coordinate with cross-functional teams to resolve quality issues and improve laboratory performance.

Qualifications & Skills:

Education:

M.Sc. (Chemistry / Analytical Chemistry) or B.Pharm / M.Pharm.

Experience:

6-15 years of experience in pharmaceutical QC (formulation / bulk drug / sterile manufacturing environment preferred).

Technical Skills:

Hands-on experience with analytical instruments (HPLC, GC, UV, FTIR, etc.). Knowledge of analytical method validation, stability testing, and impurity profiling. Familiarity with pharmacopoeias (USP, BP, IP, EP). Understanding of cGMP, GLP, and data integrity requirements.

Soft Skills:

Strong analytical and problem-solving abilities. Excellent communication and leadership skills. Good documentation and organizational skills. Ability to work under minimal supervision and manage multiple tasks efficiently.

Key Performance Indicators (KPIs):

Accuracy and reliability of analytical results. Compliance with GMP/GLP and documentation standards. Timely completion of testing and release activities. Reduction in lab errors, OOS/OOT incidents. Successful audit performance and regulatory compliance.
Job Type: Full-time

Pay: ₹15,000.00 - ₹25,000.00 per year

Benefits:

Paid sick time Paid time off Provident Fund
Work Location: In person