Job Summary
The Senior Quality Control Executive is responsible for ensuring that raw materials, in-process samples, packaging materials, finished products, stability samples, and water samples are tested in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), company SOPs, and applicable regulatory requirements. The role also supports laboratory investigations, method validation, documentation, and continuous quality improvement initiatives.
Key Responsibilities
- Perform chemical and instrumental analysis of raw materials, in-process samples, finished products, packaging materials, and stability samples.
- Operate and maintain laboratory instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, Karl Fischer Titrator, TOC Analyzer, and pH Meter.
- Review analytical data, calculations, and laboratory records for accuracy and compliance.
- Ensure timely completion of sample analysis and release activities.
- Prepare, review, and maintain analytical reports, logbooks, SOPs, specifications, and test methods.
- Conduct laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), deviations, and laboratory incidents.
- Participate in method validation, method verification, method transfer, and analytical troubleshooting.
- Monitor laboratory compliance with GMP, GLP, data integrity, and regulatory requirements.
- Coordinate calibration, qualification, and preventive maintenance of laboratory equipment.
- Support internal audits, customer audits, and regulatory inspections.
- Train and mentor junior QC analysts and technicians.
- Ensure proper inventory management of laboratory chemicals, reagents, reference standards, and consumables.
- Follow EHS (Environment, Health & Safety) guidelines and laboratory safety procedures.
- Drive continuous improvement initiatives within the QC laboratory.
Required Qualifications
- Bachelor's or Master's degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, Analytical Chemistry, or a related life sciences discipline.
- 5–10 years of experience in Quality Control within a pharmaceutical manufacturing company.
- Strong knowledge of GMP, GLP, ICH guidelines, pharmacopeias (USP, BP, IP, EP), and regulatory requirements.
- Hands-on experience with HPLC, GC, UV, FTIR, Dissolution, and other analytical instruments.
- Experience in OOS/OOT investigations, method validation, and stability testing.
- Familiarity with documentation practices and data integrity requirements (ALCOA+ principles).
Required Skills
- Strong analytical and problem-solving skills.
- Excellent documentation and report-writing abilities.
- Leadership and team management skills.
- Good communication and interpersonal skills.
- Ability to work under deadlines while maintaining high-quality standards.
- Proficiency in Microsoft Office and laboratory documentation systems.
Key Performance Indicators (KPIs)
- On-time sample testing and report issuance.
- Compliance with GMP, GLP, and SOP requirements.
- Laboratory investigation closure within defined timelines.
- Audit and inspection readiness.
- Reduction in analytical errors and repeat testing.
- Instrument uptime and calibration compliance.
- Training completion and competency development of team members.
Preferred Experience
- Experience in regulatory-approved manufacturing facilities (USFDA, MHRA, EMA, WHO-GMP, or similar).
- Experience with LIMS, Empower, Chromeleon, or other chromatography data systems.
- Knowledge of quality risk management and continuous improvement tools.
Working Conditions
- Laboratory-based role within a pharmaceutical manufacturing environment.
- May require shift work and support during audits, validations, and regulatory inspections.
Pay: ₹25,000.00 - ₹40,000.00 per month
Benefits:
- Cell phone reimbursement
- Flexible schedule
- Paid time off
- Provident Fund
Work Location: In person
