Job Id: 20200924017
Job Role: CMO Quality Manager
Experience: 5 Years
Qualification: Graduation in Chemistry, Pharmacy, Microbiology or another related science,
Job Location: Gurgaon
Salary: Best in Industry
Vacancies: Not Mentioned
Job Description GSK Recruitment 2020 Job Vacancies for CMO Quality Manager in September 2020:
The CMO Quality Manager in partner with the Supplier Relation Manager (SRM), must develop and maintain an effective working relationship with internal stakeholders and all members of the SRT, including other members of CMO including Supply and Procurement Managers, as well as contacts within Regulatory, Technical, Procurement, relevant Category Quality functions.
The Role :
Be the point of contact for Quality matters with the assigned Contract Manufacturers i.e. Recipharm, Geltec, Group Pharma and Medreich
Ensure that all aspects of the GSK products at assigned Contract Manufacturer(s) i.e. Recipharm, Geltec, Group Pharma and Medreich comply with the requirements of the GSK Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
Evaluate effectiveness of the CMO’s Quality Unit and systems and influence External Suppliers promoting robust systems under self-sufficient organizations. Escalate all serious cGMP/Regulatory compliance issues. Monitor the quality performance of the External Supplier driving remedial action where necessary. Monitor and assess External Suppliers’ key performance indicators, such as complaints and Right First Time as a mechanism to propose Continuous Improvement initiatives.
Apply appropriate Risk Management tools with each CM/External Supplier in scope, escalating and tracking significant risks requiring resolution, including complaint monitoring and trending, reporting to Quality Council, Product Incident Review Committee (PIRC) or other Corporate Governance processes, as required.
Ensure that investigations associated with assigned Contract Manufacturers are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure. Support the internal audit process where required.
Ensure timely communication of Quality Alert issues. Co-ordinate and track any remediation deemed necessary. Ensure the LOC (Market QA) is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.
Drive periodic review of Quality Systems at the CM, to complement audit process. Conduct root cause analysis reviews for identification of issues and development of remedial actions.
Review and respond to External Supplier regulatory inspections on matters that involve activities related to GSK products. Assess impact of inspection and External Supplier responses to Regulatory observations prior to submission to the associated agency.
Work with CM to establish meaningful CAPAs, in response to GSK audit observations and assure acceptable closure with the CM. Track and ensure timely and appropriate closure of effective corrective / preventive actions at assigned Contract Manufacturer(s). Take the lead to ensure that any commitments given to address audit observations (both GSK and Health Authority) by assigned Contract Manufacturer(s) are implemented as described in the agreed time frame.
Ensure that the list of material, products, contract manufacturers and suppliers is constantly up-to-date in relevant IT database (Carisma 3).
Support new product introductions from an operational perspective. Eventually review and approve significant documentation associated with the introduction or transfer of a new or existing product to CMs.
Ensure that central database like TIMS are kept up to date for Quality section.
Perform technical release of Medical Devices as per GSK procedures, if applicable.
Be able to share expertise and functional knowledge to carry out day to day activities effectively on the relevant manufacturing processes (e.g. Solid forms, derm/liquids, medical Devices & toothpastes) and to perform varied work activities with some individual responsibility or autonomy under limited supervision with regards to packaging processes (e.g. Blisters, tubes and bottles) and analytical processes (e.g. Physico-chemical and microbiology).
Minimum Level years of Experience :
5 years experience in various Technical and Quality Assurance roles.
Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment.
Previous assignment experience promoting or requiring global perspective desirable.
Project Management skills and leadership skills
Operational Excellence exposure.
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