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QA Specialist

  • Sector: Science & Pharma
  • Contact Email: aisling.lane@collinsmcnicholas.ie
  • Job Ref: 18363

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.

aisling.lane@collinsmcnicholas.ie

(021) 4320675