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QC Manager @ Milan Laboratories

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 QC Manager

Job Description

  • 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 Sciences
Functional Area / Department: Quality Assurance
Role Category: Quality Assurance - Other
Role: Quality Assurance - Other
Employement Type: Full time

Contact Details:

Company: Milan Laboratories
Location(s): Dahej

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Keyskills:   CAPA LIMS Change Management QMS HPLC OSD Instruments Injectables GLP Incident Management GMP STP

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