QA Specialist-12 month contract
QA Specialist required for an award-winning biopharmaceutical company in Cork. The QA Specialist will be responsible for the quality assurance operations activities onsite. If you have 2 + years of experience in batch record reviews in the pharma space and you are looking to join a growing leader in the industry then please reach out for more information.
Overview of Main Responsibilities: (full job spec on request)
- Reviewing production batch records and GMP documentation e.g, SOPs, reports, methods, specifications, validation protocols, quality contracts, etc., and Exceptional Documents e.g. NCRs/PNCRs, etc.
- Writing and reviewing QA department procedures and reports e.g. protocols, SOPs, environmental reports, etc. Reviewing and Approving other departmental procedures and reports.
- Participation in change control activities on site.
- Assisting in the preparation and reviewing of QA department reports and metrics e.g. monthly quality reports, discrepancy reports, exceptions reports, KPI reports.
- Participate in initiatives and action plans for the development of QA and improvement of GMP compliance.
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients
- Assist in preparation and presentation of GMP training programmes.
- Ensure QA activities are executed in line with in-house procedures and in compliance with requirements of cGMP.
- Assist in New Product Introduction Activities when required.
- Reviewing all documentation associated with batch release to ensure GMP compliance.
- Verifying the labelling of the raw material, packaging components, bulk, and finished product.
- Ensuring the follow-up of the necessary corrective actions & preventative actions implemented in consequence of a quality failure
- Participate in KPI meetings to assist the batch release process.
What the ideal candidate looks like:
- Third level degree in science based discipline.
- Minimum 2 years of experience in a regulated environment preferably in the pharmaceutical industry.
What you will get in return:
- Competitive salary (depending on experience)
For a confidential discussion and more information on the role, please contact Aisling Lane.