Assistant Manager

Description

• Plan, allocate, and monitor daily analytical work within the section.
• Hands on knowledge of current requirements for computer system validation.
• Review all relevant documents, laboratory records, and system entries.
• Qualification of Laboratory Instruments.
• Monitoring Calibration and preventive maintenance of Instruments.
• Writing SOP for new GMP system derived from CAPA or audit response, and for New Instruments, periodic revision of SOPs.
• Prepare, revise, maintain, and retrieve all QC documents as per requirements.
• Conduct monthly review of the “Format Control Audit Log” for the QC department.
• Review and verify calculator functionality and documentation.
• Ensure integrity of paper and electronic data, including audit trail verification.
• Update section-specific documents and provide data for monthly reports.
• Ensure personnel receive required training in QC procedures.
• Qualify and validate analysts for the specific tests and analytical methods being performed.
• Execute, investigate, and close Incidents, Deviations, CAPA, and LERs in the QC laboratory.
• Coordinate with cross-functional teams and other departments for investigation-related activities. Assign appropriate CAPA.
• Review ongoing investigations, collaborate with QC and Site QA members, and communicate investigation status.
• Monitor and ensure timely closure of all QMS records.
• Maintain follow-up actions for all QMS-related activities.
• Prepare the QC laboratory for internal and external audits.
• Maintain cGMP compliance across all QC operations.
• Provide timely corrective and preventive actions for internal and external audit observations.

Qualifications