Senior Quality Assurance Specialist
3 days ago
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team in Dublin, Ireland. This role is an exciting opportunity to make a meaningful impact by ensuring the highest standards of quality and compliance in pharmaceutical manufacturing.
The role involves EU batch certification and release, ensuring compliance with GMP aspects of laws governing the importation of products into the EU.
Main Responsibilities:
- Ensure a compliant operation is in place for QP certification of batches of pharmaceutical products.
- Certify all batches of Pharma products imported into EU in accordance with EU Guidance on GMP Part1, Annex 16 and Annex 21.
- Lead regulatory inspections of the QP certification process.
- Oversight of supply site operations via formal quality meetings with the site, involvement with internal audits undertaken at the sites and visits to view operations as required.
- Support regulatory inspections of supply sites, as required.
- Audits of the importation supply chain to ensure compliance with GMP, GDP and MIA authorisation, as required.
- Represent QP Importation on assigned projects, as required.
- Mentor and coach junior members of the team.
Required Skills and Qualifications:
- Scientific degree.
- Significant experience in pharmaceutical manufacturing and quality operations.
- Experience with the certification of major dose forms (tablets, cream/ointments), aseptic sterile manufacture and biopharm products.
- Experience in management of Manufacturer Importation licences.
- Knowledge of GDP regulations.
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