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Details

QA Specialist


Reference:SMC036003 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

We’re currently recruiting for an exciting opportunity with an award winning biopharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Batch Record Review & material release to ensure compliance with GMP requirements.
• Carries out tasks related to the management of batch records design and approval.
• Supports system qualification and process validation activities.• Carries out administration of the SAP Quality Management Module.
• Carries out tasks relating to the management of site change control systems.
• Compiles Annual Product Reviews.
• Supports all validation activities on site as described in the Site Validation Master Plan.
• Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
• Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
• Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
• Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
• Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
• Perform GMP audits on-site and vendor facilities as required.
• Carries out tasks related to the administration of site supplier approval process.

Education & Experience

Essential
• Bachelors Degree in a scientific/technical discipline required
• A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA 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.
• Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.

Desireable
• Experience in auditing of external suppliers, contractors and vendors.

If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480