This multinational Pharmaceutical organisation is going through exciting growth in its Cork site. They are looking for a Senior QA Specialist to join their expanding team on a permanent basis.
Overview of Main Responsibilities (full job description available on request):
- Support established products and new product introduction from a QA perspective.
- Coordinate interface between QA, Operations, and Process Development Services.
- Manage and prioritize activities of Quality Assurance Group such that customer/business, team, and individual objectives are met.
- Work with customers to design and approve Quality Agreements in line with customer and site requirements.
- Prepare and support the site for external/internal audits and Participate in level 1 & 2 audits as appropriate.
- Perform Quality Assurance SME role for Local Change Control Panels.
- QA Review & Approval of Manufacturing Batch Records.
- Report any non-compliances to the QA manager and participate in any subsequent investigation, as appropriate.
- Participate in Process Deviation & Root Cause Analysis Review.
- Coordinate deviation notifications and ensure that these are closed out within appropriate timelines.
- 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.
- Issue/approve COAs in compliance with customer requirements for each batch exported from the site.
- Where appropriate assist in the investigation/reporting of customer complaints.
- Participate in the authoring of Annual Product Reviews for the various products made on site.
- Carry out timely validation of Drug Substance analytical test results.
- Review and sign off any Laboratory Investigation Reports (LIR) associated with validated batches.
What the ideal candidate looks like:
- Relevant qualifications such as BSc; master's or Ph.D. in chemistry or related field.
- Previous experience in Quality Assurance in API manufacturing environment or related field is essential.
- Line management/coaching / mentoring experience would be an advantage.
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.