A Quality Control (QC) Manager in pharmaceutical manufacturing facilities producing Solid dosage forms, sterile injectables, oncology products, and other GMP-regulated dosage forms to manage and control all Quality Control laboratory activities to ensure that raw materials, packaging materials, in-process samples, finished products, stability samples, water systems, environmental monitoring, and microbiological testing comply with approved specifications, regulatory requirements, and Good Manufacturing Practices (GMP).
Key Responsibilities
Laboratory Operations:
· Manage day-to-day QC laboratory operations, ensure timely analysis of API samples, in process testing and complete testing of finished products testing, monitor laboratory productivity and efficiency and maintain laboratory discipline and GMP / GLP related documents for compliance.
· Ensure proper qualification, calibration, preventive maintenance, and utilization.
Stability Studies:
· To Manage and prepare Stability protocols , Sample withdrawal , Testing , Trend analysis and Shelf-life evaluation
Method Validation & Verification:
· Analytical Method Validation , Method Verification , Method Transfer , Cleaning Validation support , Hold Time Study support.
Microbiology Laboratory:
· Ensure monitoring of Environmental Monitoring, Water Testing , Sterility Testing, Media Preparation, Microbial Limit Test and Endotoxin Testing.
Compliance & Audits:
· Ensure adherence to Good Manufacturing Practices (cGMP), pharmacopeial guidelines, and data integrity rules. Capable of handling regulatory and customer inspections/audits, which includes preparation for inspection& audit compliance.
Investigations:
· Lead root-cause analysis for out-of-specification OOS/OOT closure time, CAPA effectiveness results, deviations, and laboratory incidents if any.
Team Leadership and team management:
· Decision-making , Problem-solving, Planning and scheduling , Communication , Risk assessment and Regulatory audit management
· Train, mentor, and evaluate laboratory analysts and technicians.
Minimum Qualifications:
Education:
· Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, Microbiology.
· Additional qualification in Quality Management or Regulatory Affairs is desirable.
Experience:
· Minimum 3 -5 years of hands-on analytical lab experience in a pharmaceutical industry.
· Should have FDA Approval minimum in Chemical Testing, Instrument Testing and Microbiology Section.
Technical Skills:
· Proficiency with advanced lab instrumentation (such as HPLC, GC, and UV-Vis spectroscopy) and strong knowledge of pharmacopoeial standards Like I.P. B.P. etc.
· Analytical method validation , Stability study management, Instrument qualification (IQ/OQ/PQ) etc
Pay: ₹50,000.00 - ₹60,000.00 per month
Work Location: In person
