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Milan Laboratories
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QC Manager

QC Manager

Milan Laboratories

15 - 24 years

14 - 19 Lacs

Dahej

Posted:6 hours ago| Platform:

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Skills Required

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

Work Mode

Work from Office

Job Type

Full Time

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 dipika.parmar@milanlabs.com

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Milan Laboratories

www.milanlaboratories.com

Pharmaceuticals

Milan

200 Employees

6 Jobs

Key People

Dr. Mario Rossi

CEO
Sara Bianchi

CTO
Giovanni Verdi

CFO

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QC Manager