This multinational Pharmaceutical organisation is going through exciting growth in their Cork site. They are looking for 2 X QA Specialists to join their expanding team on a permanent basis.
Overview of Main Responsibilities (full job description available on request):
- Perform the role of key QA representative for assigned products (intermediate and API).
- QA Review & Approval of Manufacturing Batch Records.
- Use of Process Explorer IP21 to trend Quality Critical Parameters for Drug Substance and Intermediates..
- Carry out QA review of product process deviations on an ongoing basis. to review the data for any recurring deviations.
- Co-ordinate deviation notifications and ensure that these are closed out within appropriate timelines
- Ensure appropriate investigations are performed on all deviations.
- Support Implementation and maintenance of Process Deviation Management (PDM) for products
- Perform API Batch Release.
- Ensure QA approval of original/revised manufacturing batch records (MBR's) and archival of historic documents.
- Participate in GMP Audits.
What the ideal candidate looks like:
- Relevant qualification such as BSc; masters or PhD in chemistry or related field.
- Previous experience in Quality Assurance in API manufacturing environment is preferred.
What you will get in return:
- Competitive salary.
- Private medical insurance.
- Free onsite parking.
For a confidential discussion and more information on the role, please contact Aisling Lane.