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QA Specialist

Ref: 921119

  • €40,000 - €50,000
  • 15 Feb 2019
  • Cork (Centre)
  • Perm

A key client has an exciting opportunity for a QA specialist to join their team in Cork. Working as part of a high performing team you will be responsible for tasks and projects including Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review, Product Quality Support and Validation compliance activities.

As a QA Specialist, your typical day may include:

Batch Record Review & material release. Review & Approval of Event, Deviations, and Customer complaints. Management of batch records design and approval. Administration of the SAP Quality Management Module. Management of site change control systems. Compiles Annual Product Reviews. Supports all validation activities on site as described in the Site Validation Master Plan Supports system qualification and process validation activities. Review and approve SOPs/work instructions/forms from other departments on behalf of Quality Assurance. Co-ordinate and assist in the preparation for regulatory and customer GMP inspections of the site. Perform GMP audits on-site and vendor facilities as required. Carry out tasks related to the administration of site supplier approval process. What you’re great at: Excellent interpersonal skills. Ability to operate as part of a team is critical. Customer focus. Innovative. Excellent communication skills both written and verbal. Attention to detail. Good problem-solving skills. Results and performance driven. Adaptable and flexible. Decision making. Excellent time management skills with good multi-tasking ability.

About You:

To be part of this high performing team you will have Bachelor’s Degree in a scientific/technical discipline required – Level 8. A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. Knowledgeable of FDA/HPRA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Focus on patients and customers at all times. For more on the role call Nigel on 021 4221000 or send your CV for consideration.