Expert in Pharmaceutical System Validation

5 days ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €90,000 - €110,000
System Compliance Specialist

As a key member of our operations team, you will be responsible for ensuring the compliance and validation of new drug product manufacturing facilities.


Key Responsibilities:
  • Lead the planning, execution, and documentation of commissioning and qualification activities.
  • Develop and maintain area-specific plans, test strategies, and support documentation.
  • Collaborate with cross-functional teams to ensure timely and compliant delivery of commissioning and qualification outcomes.
  • Provide subject matter expertise on pharmaceutical standards and regulatory expectations.
  • Review, approve, and ensure completeness of commissioning and qualification documentation.
  • Track and resolve discrepancies, deviations, and change controls related to commissioning and qualification activities.

Requirements:
  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 5-10+ years of experience in commissioning and qualification within a GMP-regulated environment.
  • Proven leadership experience managing cross-functional teams or specific project areas.
  • Strong technical knowledge of commissioning, qualification, and validation practices.
  • Deep understanding of regulatory guidelines and industry best practices.
  • Experience with digital tools.
  • Excellent communication, leadership, and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to manage multiple priorities in a fast-paced, dynamic environment.

About Us:

We are a specialist consultancy recruiting professionals for organizations throughout Ireland, UK & Europe.

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