Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
This position reports to the Quality Lead and will be part of the Quality Organisation at Carlow.
- Responsible for ensuring that the process for the manufacture of drug product at is in compliance with cGMP and the associated regulatory requirements.
- Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
- Provision of advice on all aspects of Regulatory GMP practices and systems.
- Design, develop and deliver training courses for QA/QP function on aspects on aseptic processes for finished pharmaceuticals.
- Actively participate in Plant/Quality committees and works with other site functional groups, such as the Production and Maintenance to help set direction for GMP initiatives.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends.
- Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
Support the introduction of new products onto site in relation to Quality oversight, covering the end to end product release strategy.
Typical Minimum Education:
- 2+ years' experience of working as a releasing QP IN Drug Substance and/or aspectic filled pharmaceuticals
- Knowledge of EU/US quality related pharmaceutical regulations
Typical Minimum Experience:
- Experience of conducting quality based investigations and root cause analysis.
- Provide quality input to ensure batch impact is properly assessed.
- Work with cross functional team including technical SME's to ensure that appropriate corrective and preventative measures are assigned.
Qualified Person requirements as defined in EC directive 2001/83/EC and 2001/20/EC.