- Reference: AJ42740
- Job Type: Permanent
- Location: Galway, Offaly, Westmeath
- Category: Bio-Pharmaceutical
Our Client, a specialist pharmaceutical manufacturer has a requirement for a suitably qualified and experienced QA Specialist on a 6 month fixed term contract for their manufacturing facility in Athlone.
QA Specialist responsibilities:
- Ensuring the effective operation of QMS processes, specifically maintenance of Quality records
- Acting as a point of contact for representatives of other functional areas for queries regarding the QMS
- Generation and/or revision of QMS Standard Operating Procedures (SOPs)
- Reviewing and approving other SOPs (e.g. Production, Engineering, QC) and documents (e.g. Specifications, Master Batch Records)
- Providing oversight of internal compliance with SOPs, logbooks and general GMP to ensure audit readiness
- Reviewing and approving records which are part of the QMS (which may include, but is not limited to: Batch Records, QC data, Validation data)
- Preparing batch records for QP review and approval
- Participate in the team for internal and third party audits
QA Specialist will have:
- BSc/MSc in science discipline required
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas is essential
- QC analytical experience desirable
- Good knowledge of quality systems, FDA and EU GMP regulations and ICH guidelines.
For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email firstname.lastname@example.org
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