- BBBH813663 Jun 13, 2022 Competitive
I am delighted to be collaborating with my client on an exciting new position for a QP manager in the biopharmaceutical space based in Dublin.
This is a permanent role with excellent opportunities within to progress and grow. In this role, you will be working to release commercial and clinical drug substance, drug product and finished products to support supply for rare diseases. This person will be responsible for ensuring that licensed finished products are certified and released to market in accordance with EU directive 2001/83/EC and in accordance with the requirements of Annex 16.
To be suitable for this role you must have previously acted an eligible QP on a license with 2 years' experience and a further 8 years' experience in a GMP related environment in biopharmaceuticals or pharmaceuticals. Knowledge of biopharmaceutical manufacturing, packaging, testing, and distribution processes associated with global regulatory GMP/GDP requirements is essential. Extensive knowledge around pharmaceutical quality also necessary. This person must understand regulatory compliance maintenance. You must be a driven and motivated individual with the ability to multitask, prioritize and meet tight deadlines.
- Ensure independence of the QP on decisions on quality related matters.
- Builds partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements.
- Provide quality and compliance guidance on all critical and major quality matters.
- Provide quality review and approve Annual Product Quality Review.
- Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management, the Change Control Programs and Quality Agreements.
- Creates an environment for 'right first time' in focusing on principles of lean, visual management and building in efficiencies as necessary from a systematic and compliance perspective.
- Support Regulatory Inspections and be a representative in front of Health Authorities and Regulatory Bodies.
- Provide audit support as required for internal auditing program and supplier audits.
- Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
- Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice
If this role is of interest, please apply now or contact me on firstname.lastname@example.org or 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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