Lead Pharmaceutical Quality Control Analyst
Core
Lead and manage pharmaceutical quality control testing and compliance for manufacturing operations, ensuring product quality and regulatory adherence.
Role type
Lead pharmaceutical quality control analyst (supervisory)
Builds
Pharmaceutical products meeting quality standards
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
HPLC, GC, UV-Vis, IR spectroscopy, wet chemistry, GMP, ICH guidelines, OOS investigation, CAPA implementation, LIMS, laboratory equipment qualification, team leadership, regulatory liaison
Preferred skills
LIMS experience
Responsibilities
Lead and manage the day-to-day operations of the Quality Control laboratory, Develop and validate analytical methods for raw materials, in-process samples, and finished products, Ensure all QC testing is performed in compliance with GMP and pharmacopoeial standards, Review and approve analytical data, batch records, and validation reports, Investigate out-of-specification (OOS) results and implement corrective and preventive actions (CAPAs), Manage the qualification and calibration of laboratory equipment, Train and mentor QC analysts, Liaise with regulatory authorities during inspections and audits, Contribute to the continuous improvement of quality systems and processes, Maintain accurate and organized laboratory records, ensuring data integrity
