Senior Technical Compliance Specialist

5 days ago

Naas, Co Kildare, Ireland beBeeCompliance Full time €80,000 - €110,000

Job Description:

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This is a contract role supporting the Technical Compliance Team. The position requires preparation and execution of commissioning and qualification protocols for site systems/equipment.

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Responsibilities:

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  • ">
  • Provide input into all aspects of C&Q from design through to completion">
  • Support and participate in the design of systems/equipment to ensure cGMP compliance">
  • Prepare C&Q protocols as required (e.g. URS's/SRS's, Plans, Impact Assessments)">
  • Review and approve documents prepared by contractors/vendors">
  • Execute C&Q protocols as required">
  • Prioritize C&Q activities in line with site/project schedules">
  • C&Q system/equipment/components as per site procedures">
  • Strong collaboration with Quality Department">
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Requirements:

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A third-level degree and relevant experience are required. A minimum of 5+ years' experience in the Pharmaceutical (API) Industry is also necessary.

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Experience preparing and executing commissioning and qualification protocols and reports is essential. Experience in a cGMP regulated environment is also required.

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Extensive experience of commissioning and qualification of production systems/utilities/facilities and change management is beneficial.

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Knowledge and experience of Project Delivery Processes (PDP) and current Good Engineering Practices (GEP) would be advantageous.

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Knowledge of ABB Industrial IT control systems and Pharmaceutical facility local/control instrumentation is desirable.

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Experience working within a Technical Compliance/Project team in a multinational corporate environment is preferred.

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Familiarity with ASTM 2500 and/or Risk-Based Qualification approach would be beneficial.

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Benefits:

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This role offers an opportunity to work on a diverse range of projects and collaborate with a skilled team.

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The successful candidate will have the opportunity to develop their skills and knowledge in a dynamic and supportive environment.

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Contact Information:

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Please submit an updated CV for consideration.

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