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.