- JN -012024-1954507
- Jan 22, 2024
An exciting new position for an experienced QP to join a growing team within the pharmaceutical industry based in Waterford on a permanent basis.
The responsibility of the QP is to ensure that licensed product is certified and released to market in accordance with EU directive 2001/83/EC, 2004/94/EC and in line with Annex 16.
The successful candidate will have 5-8 years' experience working as a QP named on the MIA. Extensive experience and knowledge in GMP and working within QA in a Pharmaceutical environment. Proven leadership experience essential for this role. Experience in biologics, sterile manufacturing and clinical trials regulation would be desirable. Post graduate qualification required.
- Manage the batch disposition process to ensure timely release of product.
- Ensure the batch disposition process maintains compliance with site practices & regulatory requirements.
- Support major investigations, ensuring all product deviations are closed prior to batch release.
- Participate in cross functional teams as Quality/Qualified Person representative.
- Provide additional QP support to quality related issues, as the need arises.
- Participate on internal committees/teams, as required.
- Provide advice and direction to other departments on quality issues.
- Ensure independence of the QP on decisions on quality related matters
- Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements.
- Provide audit support as required for internal auditing program and supplier audits.
If this role is of interest, please 'apply now' or contact me on 021 2300 300 to discuss this opportunity.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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