Description

We are seeking an experienced QC Supervisor / Assistant Manager to oversee Quality Control activities in an Active Pharmaceutical Ingredient (API) manufacturing facility. The candidate will be responsible for laboratory operations, work planning, team management, analytical instrument troubleshooting, investigation of quality incidents, and compliance with regulatory and quality standards. Key Responsibilities 1. QC Operations and Work Planning  Plan, prioritize, and allocate daily QC activities among team members based on production requirements and sample priorities.  Supervise routine analysis of raw materials, intermediates, in-process samples, finished APIs, and stability samples, as applicable.  Ensure timely completion of analytical testing, documentation, and reporting.  Monitor laboratory workload, turnaround time, and team performance.  Ensure availability and proper utilization of laboratory instruments, chemicals, reagents, and reference standards. 2. Team Handling and Supervision  Lead, guide, and supervise QC analysts and laboratory personnel.  Assign responsibilities, monitor performance, and ensure adherence to approved SOPs.  Provide training on analytical methods, laboratory safety, GMP practices, and documentation requirements.  Coordinate with Production, QA, R&D;, and other relevant departments to resolve quality-related issues.  Ensure effective shift planning and resource utilization, where applicable. 3. HPLC/GC Troubleshooting  Troubleshoot analytical instrument issues related to HPLC and GC systems.  Identify potential causes of analytical failures, abnormal chromatograms, system suitability failures, and instrument performance issues.



 Coordinate with instrument service engineers and relevant teams for corrective maintenance, as required.  Ensure proper instrument calibration, qualification, maintenance, and usage documentation.  Support method troubleshooting and ensure reliable, reproducible analytical results. 4. Quality Management System (QMS)  Ensure compliance with applicable GMP requirements, approved SOPs, and internal quality procedures.  Review and maintain QC records, analytical data, laboratory logbooks, and test reports.  Participate in deviation management, CAPA, change control, and other QMS activities.  Ensure adherence to data integrity principles and good documentation practices.  Support internal audits, customer audits, and regulatory inspections. 5. OOS/OOT Investigation and Incident Management  Lead or support investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results.  Investigate analytical discrepancies, laboratory incidents, and unexpected test results.  Perform systematic root cause analysis and recommend appropriate corrective and preventive actions.  Ensure investigations are scientifically justified, properly documented, and completed within defined timelines.  Track CAPA implementation and verify effectiveness, as applicable. 6.



Compliance and Continuous Improvement  Ensure QC activities comply with applicable GMP, GLP, pharmacopoeial, and regulatory requirements.  Identify opportunities to improve laboratory efficiency, analytical reliability, and documentation quality.  Maintain laboratory housekeeping, safety, and compliance standards.  Support continuous improvement initiatives within the API QC laboratory. Mandatory Requirements  Qualification: M.Sc. in Chemistry.  Experience: 8–10 years in pharmaceutical Quality Control, with mandatory API QC experience.  Proven experience in work planning, laboratory supervision, and team handling.  Hands-on knowledge of HPLC and GC troubleshooting.  Strong understanding of QMS and pharmaceutical quality systems.  Experience in OOS/OOT investigations and root cause analysis.  Valuable knowledge of GMP, laboratory documentation, data integrity, and regulatory compliance. Preferred Skills  Experience in API manufacturing and analytical testing of pharmaceutical intermediates and finished APIs.  Knowledge of analytical method validation and method transfer.  Familiarity with CAPA, deviations, change control, and risk assessment.  Strong leadership, problem-solving, communication, and decision-making skills. Position Summary Parameter Requirement Job Title QC Supervisor / Assistant Manager Department API Quality Control Qualification M.Sc. Chemistry Experience 8–10 Years Vacancies 1 Mandatory Experience API QC Technical Skills HPLC/GC troubleshooting Quality Systems QMS, OOS/OOT investigations Leadership Skills Work planning and team handling

📌 Assistant Manager (Mumbai)
🏢 Cadila Pharmaceuticals
📍 Mumbai