Job Description Summary
As a Quality Control Assistant Manager, responsible for coordinating and overseeing day-to-day laboratory operations to ensure compliance with current GMP, regulatory requirements, and internal quality standards. The role involves effective planning, supervision, and monitoring of group activities, ensuring timely completion of analytical testing, investigations, and laboratory commitments. Experienced Quality Control professional with expertise in laboratory management, analytical review, GMP compliance, investigation management, documentation control, SOP and analytical method lifecycle management, personnel training, and regulatory compliance. Proven ability to lead laboratory teams, ensure data integrity, maintain inspection readiness, and deliver quality objectives through effective planning, supervision, and continuous process improvement.
Job Description
- Supervising and coordinating the activities of QC analysts and ensuring optimal utilization of laboratory resources.
- Reviewing and approving quality control documents, including analytical data, laboratory records, stability studies, investigations, protocols, reports, and certificates.
- Ensuring laboratory compliance with cGMP, data integrity requirements, SOPs, safety guidelines, and regulatory expectations during routine operations.
- Leading and participating in laboratory investigations related to OOS, OOT, deviations, atypical results, and laboratory incidents, including root cause analysis and implementation of CAPAs.
- Preparing, reviewing, revising, and maintaining Standard Operating Procedures (SOPs) and other controlled quality documents.
- Reviewing, preparing, and updating specifications (SPECs), Standard Test Procedures (STPs), analytical methods, protocols, and related quality system documents.
- Providing technical guidance and troubleshooting support for chromatographic and laboratory-related issues.
- Planning and conducting training programs to enhance personnel competency and ensure compliance with current procedures and regulatory requirements.
- Monitoring analyst qualifications, training effectiveness, and periodic evaluations.
- Coordinating instrument qualification, calibration, maintenance activities, and ensuring laboratory equipment remains in a compliant state.
- Supporting method validation, method transfer, verification, and stability studies as per regulatory requirements.
- Collaborating with cross-functional departments including QA, Manufacturing, Regulatory Affairs, and R&D to support product quality and compliance objectives.
- Driving continuous improvement initiatives aimed at improving laboratory efficiency, compliance, and operational excellence.
To take up any additional responsibilities assigned by the Manager or QC Head.
