Description
Pharmaceutical company based in Dublin are seeking a Senior QA Specialist to join their Quality department. The Senior QA Specialist will be a core member of a growing site Quality Assurance team supporting manufacturing operations and will serve as Quality point of contact for manufacturing.Duties of the QA Specialist:
- Quality representative for QA team within manufacturing.
- Review and approval of Non Conformances and CAPAs.
- Write, review and approve Standard Operating Procedures.
- Perform quality walks of manufacturing area.
- Performs Quality Audits to ensure compliance with cGMPs.
- Approves Systems validation protocols on behalf of QA.
- Review and approve Master Batch Records.
- Compile QC and Manufacturing batch records and reviews for compliance to cGMPs.
- Prepare deviation trend reports and Annual Product Reports.
- Train new team members.
Requirements:
- As the Senior QA Specialist you will be working in an aseptic manufacturing environment so experience in this environment is essential.
- At least 5 years related experience.
- Third Level Degree in a science discipline.
- In dept knowledge of GMP and aseptic manufacturing techniques.
If you are interested in this role and have the relevant experience contact Anna Mooney on or apply with your CV.
Sthree UK is acting as an Employment Agency in relation to this vacancy.