Leading the Quality Control Teamaccording to the norms of GMP (Good Manufacturing Practices) to ensure international quality standards and adherence to various regulatory requirements.
Developing and reviewing cGMP compliance related documents like global procedures, methods, standards, specification, validation protocols, summary reports.
Implementation of management system for Change control, CAPA, OOS, Risk analysis, deviation management system, incidents (Lab ware LIMS, eQMS,Track wise) and complaint management system.
Actively participated in QTA between CMO and receiving/transferring site.
Review and approval of APQR.
Root cause analysis/ Failure investigation and corrective and preventive action planning
Change control management system, CAPA, OOS, deviation management system, incidents
Corrective and preventive action planning (CAPA) against the regulatory requirement.
Implementation of CAPA effectiveness checks against the regulatory and existing quality system requirements.
Deep knowledge in LIMS (Caliber/ LabWare management system and Thermo LIMS).
GAP assessment of the quality system for process optimization and to assess the regulatory requirements against the gaps observed.
Development and review of cGMP compliance related documents like global procedures, methods, standards, specification and validation protocols, summary reports.
Immediate Joiners will be prefered. Kindly share resume on di**********r@mi******s.com
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full time