Quality Control Executive

Job Description QC Executive (API / Lifesciences)

Department: Quality Control (QC) HPLC
Industry: Pharmaceutical API / Lifesciences
Job Location: Padra, Vadodara, Gujarat
Designation: Executive – Quality Control
Experience: 2–5 Years

Job Purpose

To perform analytical testing of raw materials, intermediates, finished APIs and other samples using HPLC and other analytical instruments, ensuring compliance with approved specifications, established procedures and applicable GMP requirements.

Key Responsibilities

• Perform HPLC analysis of raw materials, intermediates, finished APIs and in-process samples as per approved specifications and analytical methods.
• Operate, calibrate and maintain HPLC instruments and other analytical equipment as per established procedures.
• Prepare mobile phases, buffers, standard solutions, sample solutions and reagents required for analytical testing.
• Execute routine QC testing and ensure accurate recording, calculation, review and reporting of analytical results.
• Follow approved Standard Operating Procedures (SOPs), analytical methods, pharmacopoeial requirements and Good Laboratory Practices (GLP).
• Maintain laboratory records, analytical worksheets, instrument usage logs and other relevant QC documentation in accordance with data integrity requirements.
• Identify and report Out of Specification (OOS), Out of Trend (OOT) results, deviations and other laboratory discrepancies to the reporting manager.
• Ensure proper handling, storage, identification and traceability of samples, standards and reagents.
• Support instrument calibration, preventive maintenance, troubleshooting and laboratory investigations.
• Maintain laboratory housekeeping, safety practices and compliance with applicable cGMP requirements.
• Coordinate with other QC team members to ensure timely completion of analytical testing and reporting.

Educational Qualification

• M.Sc. in Chemistry / Analytical Chemistry or equivalent relevant qualification.
• Candidates with relevant pharmaceutical analytical laboratory experience will be preferred.

Required Skills and Experience

• 2–5 years of experience in a Quality Control laboratory within the API / Lifesciences pharmaceutical industry.
• Hands-on experience in HPLC operation, method execution, chromatographic data interpretation and result calculations.
• Working knowledge of analytical method procedures, system suitability requirements and instrument troubleshooting.
• Understanding of GMP, GLP, data integrity and QC laboratory documentation.
• Knowledge of OOS/OOT handling and laboratory investigation procedures will be an advantage.
• Good analytical skills, attention to detail and the ability to work effectively within a team.

Preferred Candidate Profile

Candidates with practical experience in HPLC analysis of pharmaceutical APIs, intermediates and raw materials, along with sound knowledge of QC laboratory practices and regulatory compliance requirements.

Interested candidates may share their updated CV along with current CTC, expected CTC and notice period.