Description
An Expanding pharmaceutical company based in North Dublin is seeking a experience QA professional to join their team.Responsibilties:
- The monitoring of compliance with the requirements of current Good Manufacturing Practice
- Liaising with Production, QC and Clinical departments on various activities.
- Management of the Pharmaceutical Quality System Documentation system, including but not limited to;
- Control of master procedures and batch documentation
- Maintenance of the SOP manuals and circulation of SOP'
- Performing Internal Audits and Quality System Reviews as scheduled
- Management of the Pharmaceutical Quality System databases
- Management of the Material Files System
- Management of record retention system (paper based system employed at Sigmoid Pharma)
- Participation in management review of process performance and product quality
- Update GMP documents as required
- Provide input and review and where appropriate approval of procedures, prepared by others which have no impact on product quality.
- Administration of the Change Management System and approving changes (where appropriate) that have no impact on product quality.
- Providing Quality Representative review as appropriate.
- Periodic review of Logbooks, calibration forms, material records etc.
- Administration of the Labelling Control System
- Provide support to the GMP training of all relevant personnel
- Assisting the QP with their duties which may include the following;
- Initial review of batch records, ensuring that product has been manufactured and packaged according to the relevant batch record
- Assist in the compilation of Product Spec Files
Requirements
- Educated to degree level (Life Sciences or Chemistry)
- 4+ years industry experience in a hands on QA role
To hear more about the role and company please contact me Anna Mooney or apply below with an up to date CV.