Description
Quality Assurance Manager/QP - Cork - 12 Month Contract
Optimus Search is currently in partnership with a leading Pharmaceutical manufacturer looking to recruit an experienced QA Manager and QP at their site in Cork on a 12 month contract.
Main Responsibilities:
- Tracking and management of batch release KPI targets.
- Investigation, tracking and monitoring the completion of deviations and non-conformances such that they have been adequately investigated and closed out to ensure that batches are acceptable for release.
- Review and collation of Marketing Authorization data to ensure information is appropriate for the QP certification of product batches.
- Review and approval of batch release data acting as QP on the appropriate MIA.
- Management and review of Quality Standard Operating Procedures relating to the quality control and product review processes
- Ensure a program is in place to provide necessary training for Quality Control staff to fulfil their objectives and responsibilities.
- Ensure that all products are handled in accordance with current safety instructions.
Key Requirements:
- Educated to degree level in Pharmacy, Chemistry, Biology, or relevant discipline
- Be suitable to be nominated as a Qualified Person as satisfying Articles 49 & 50 of EU Directive /EC and the amended /EC, along with current listing on Indicative Register for Human Medicinal Products.
- Have substantial experience on a site holding a current Manufacturers License or Manufacturers Import Authorization.
- Experience auditing suppliers and third party contract manufacturers
If interested please respond with an updated C.V.