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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

QA Specialist (hybrid)


Reference:RK8318 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

QA Specialist (hybrid)
RK8318
Contract – 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical 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 administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
  • Carries out tasks related to the management of batch records design and approval.
  • 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.).
  • Supports system qualification and process validation activities.
  • 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.
  • Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
  • Carries out tasks related to the administration of site supplier approval process.


Experience and Education:
  • Bachelors Degree in a scientific/technical discipline required
  • 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
  • Experience in auditing of external suppliers, contractors and vendors



If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.