Biotech Compliance Specialist

1 day ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €25 - €33

Job Title: Biotech Quality Assurance Professional

Location: Dublin, Ireland

Our client is a leading international Biotechnology company with a state-of-the-art manufacturing facility in Dun Laoighaire, South Dublin.

We are seeking an experienced QA Specialist to join our team. This is an excellent opportunity to contribute to the development and maintenance of site quality systems.

About the Role:

The successful candidate will be responsible for ensuring sustained compliance initiatives, including execution of gap assessments in support of revised operating standards and/or corporate policies & procedures.

Key Responsibilities:

  • Development and maintenance of site quality systems, quality compliance and related procedures and processes.
  • Quality direction and input at Change Control and Deviation Review Boards.
  • Oversight of change control and Deviation/CAPA records.
  • Regulatory updates and new guidance/requirements.
  • Trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM.
  • Effective implementation, revision, and optimisation of self-inspection, audit, and key compliance systems.

Requirements:

  • University degree in Engineering or Science related discipline preferred.
  • Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Excellent written and verbal communication skills.
  • Experience working with dynamic cross-functional teams and proven abilities in decision making.
  • Detailed knowledge of applicable Regulatory requirements.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.

What We Offer:

  • Contract role.
  • On-site location with hours from 08:00 to 17:00.
  • On-Call duties as part of rotation.

Benefits:

  • Opportunity to work with a leading international Biotechnology company.

Company Overview:

This is a contract role with competitive hourly rate.

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