Assistant Manager, Quality Control

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.

Responsibilities

• The role involves effective planning, supervision, and monitoring of group activities, ensuring timely completion of analytical testing, investigations, and laboratory commitments.
• 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.
• 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.