Description
Qualified Person - Bio pharmaceuticalsType - initially 12 months
Location - Ireland, South West
One of our global Pharmaceutical leaders is looking for a Qualified Person to join their team to work in the Bio pharmaceutical sterile manufacturing facility, to provide Quality Oversight in order to ensure that the products are being manufactured in a fully compliant and GMP manner and to perform the QP Release of these products.
Key Responsibilities
• A principal responsibility of the incumbent involves QP releasing of products to downstream site, with the assurance that the goods were manufactured in conformance with all applicable policies / procedures and in Compliance with all governing Regulations.
• 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.
• Assure 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.
• Act as a liaison of contact between External Manufacturer and Merck site personnel.
• Contribute to EQA Management Operational and Strategic Initiatives.
• Promotes and participates 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’s assigned to you.
• Provide Quality Oversight to the preparation of the Annual Product Review Report for the products associated with the CMO.
• Tracks and monitors Quality performance of the external manufacturer.
• Assists in the co-ordination of significant investigations, including Fact Findings. Assist in the co-ordination of any product recall involving the external manufacturer.