Up to €70,000
over 1 year ago
A fast-growing pharmaceutical company based in West Ireland is looking for a QA Manager & QP to join their team on a permanent basis. This company is at a very exciting stage with major growth as they have products coming out to the market. This role would be working as a QP on biologics products.
The position will be focusing on QA activities in support of the process through the Product Release Function and making sure that the products meet regulatory requirements throughout every stage of the process, in particular FDA & EMA regulations.
Key responsibilities include but are not limited to the following:
- Manages the batch disposition process to ensure timely release of products and will have QA oversight of all activities in the business unit ensuring the necessary GMP requirements
- Support to the Associate Director in addition to the Business Unit Leader in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as laid down by the FDA, EU and regional Ministries of Health as relevant.
- The QP will approve all records generated by the business unit, including but not limited to batch records, laboratory certificates of analysis, deviations, validation documents and product quality review reports.
- Represent the company in all business unit Ministries of Health inspections, ensuring the unit is audit-ready. Ensure any non-conformances and open commitments related to the business unit are addressed.
- Support the site quality plan and ensure plan execution
- Coordinate compliance initiatives
- Support the Site Quality Risk Management Program
If this role could be of interest or any questions, don’t hesitate to get in touch!