Manager Microbiology

Standort: Pakistan - Sindh - Karachi Datum: Jul 22 2022 Job Purpose: Ensuring all the activities in Microbiology Lab are being performed as per the GSK specifications and regulatory requirement and ensure that Microbiological testing methods, instrumentation and procedures meet cGMP, EHS, QMS, SOPs, Corporate requirement and regulatory standards. Manage timely availability of the resources to ensure all the requirements related to Microbiology are fulfilled and no delay in release and testing of products. It also ensures that the input materials are within the microbiological specifications. The sterile products are being manufactured within a controlled environment, All the above-mentioned activities to be achieved, in the presence of a Microbiology Lab Manager, under whose supervision all the required responsibilities are maintained and achieved Education, Experience & Skills: BS. Biology/ BS. Microbiology 5 or more-year experience of working in managerial position in Pharmaceutical Organization Good leadership skills Decision making ability Good technical skills in Microbiology Job Responsibility: To ensure compliance with regulatory requirements, Product standard and Technical Standards. To comply with new local regulatory requirements, Pharmacopoeia requirements and internal and external audits. To ensure that microbiological analysis of commercial stability, monitoring formulation development and post marketing surveillance of the products manufactured at site. To maintain microbiology lab equipment performance by developing operations procedure review validation reports, ensuring staff compliance, arranging equipment replacement service and repair. To maintain complete operational requirements by ensuring appropriate resources available to test, reviewing specifications and methods. To ensure timely releases of the products as per production plan. Oversee testing, environmental monitoring and utilities in consultation with stakeholders. To ensure and supervise validation activities of Microbiology Lab as per SVMP/VMP. To ensure validation of new products or existing products with approved changes. To respond to the queries of local regulatory within the stipulated time. Provide support in non-conformance handling and investigations Check and review SOPs of other functions where input from quality is required. To plan, supervise and conduct all level of Audits and complete ali requirements. To prepare and monitor OPEX and CAPEX, incorporate and monitor manpower plans. Kontaktinformationen: Sie können sich für diese Position online bewerben. Klicken Sie dazu auf die Schaltfläche