Telephone: 091 730022
Senior Qualified Person
Our client a leading biotech company based in Cork is looking for a Senior QP to join their team. For more than 25 years this company has been a global leader in the field of biomedicines
The QP is responsible for controlling batch release as per Annex 16 to the EU Guide to Good Manufacturing Practice in the Cork facility that is now operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments. If you are looking to join a dynamic team with excellent career progressions then read below:
Key Responsibilities of QP role:
- Responsible for certifying DSP batches prior to release to filling site.
- Ensure that the batch and it's manufacture comply with GDP; GMP; Marketing authorization; IMPD; Import License etc, depending on the product requirements
- Maintain oversight of deviations and change controls and ensures that any issues which have a regulatory impact are notified to health authorities and mitigated as required
- Ensures that all necessary tests and checks have been performed prior to batch release.
- Ensures that all necessary production and quality control documentation has been completed and endorsed by authorized staff
- Attends QMR review meetings to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
- Maintains knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract test labs
- Maintain knowledge and experience up-to-date. If a new product type is introduced the QP should ensure that they have gained the relevant knowledge and experience necessary to complete QP duties.
- Maintains oversight of issues/escalations related to batches post release ensuring that appropriate actions are taken as required.
- Supports QA colleagues with product quality / license impact assessment for deviations
Education, Experience and Skills
- MSc or Higher Diploma in Pharmaceutical Sciences/ Pharmaceutical Manufacturing Technology which fulfils the QP educational requirements.
- Industry experience within a QP role within a regulated biologics or pharma industry.
- Knowledgeable of FDA/EMA regulatory requirements
- Excellent social and communication skills
- Self-driven and keeps up to date with regulatory, technical developments within the industry.
- Acute attention to detail
- Excellent team player with strong customer focus
For further information on this Senior Qualified Person (QP) role in Cork please contact Bimi Felix on 091730022 / email@example.com
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