QA Specialist (Engineering)
Our Client, Multinational company based in Cork are currently recruiting for QA Specialist (Engineering) role . This position will be suitable for those with experience in working at IMB/FDA regulated facility with superior technical knowledge of Validation or Compliance and experience in CAPA and strong technical writing.
• This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation based on Good Manufacturing Practice (GMP).
• These activities include review and approval of change controls, nonconformance investigations, and protocols.
• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance .
• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
• Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
• Carries out tasks related to the administration of project and site nonconformance management systems:
• Reviews and/or approves nonconformance investigations and their associated documentation.
• Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
• Carries out tasks related to the management of project and site change control systems: Reviews and/or approves change control requests, implementation actions, and request closures.
• Bachelor’s Degree in a scientific/technical discipline required.
• A minimum of 2 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities
• Experience in statistical sampling plan development.
• Experience in a biopharmaceutical or pharmaceutical plant
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255