Category

Description

Responsible for implementing Quality Control policy supporting the compliant supply of product by external manufacturers of sterile pharmaceuticals / biologics / vaccines, by means of a risk based quality oversight, support and technical advice, counselling of manufacturing site senior leadership and providing on-site supervision as appropriate
Provides Quality Control oversight for method validations/method transfers and method improvements at external parties
The incumbent will review the executed batch records and ensure that the product has been produced in compliance with the approved batch record instructions
Follow up and ensure timely close out of all corrections associated with the Batch Record Review
Participate in routine weekly Tier 2 meetings / teleconferences between ExM and Contract Manufacturing Operations (CMOs)
Co-ordinate the full investigation into all Customer Complaints received for any of the batches manufactured by the CMO s
Assures CMO compliance with established policies / procedures of the Division and Corporate and complies with all applicable governmental Regulations (GMP, FDA, etc.)
Responsible for on-going execution of the Quality Agreement with the External Party.
Contribute to EQA Management Operational and Strategic Initiatives
Promote and participate in the implementation and maintenance of the SHE / EHS programmes relevant to you
Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up CAPA

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