Senior Quality Assurance Specialist

4 days ago

Dundalk, Louth, Ireland beBeeValidation Full time €75,000 - €110,000

We are seeking an experienced professional to join our team in a key role within the quality and innovation department of a leading life science organization based in Ireland.

About the Role
  • This position involves executing qualification and validation activities, ensuring compliance with cGMP and company procedures throughout various phases of product development, from design to launch.
  • The ideal candidate will be responsible for authoring, reviewing, executing, and approving testing protocols and reports.
  • They will also contribute to project delivery, participate in project teams, vendor inquiries, troubleshooting, and monitoring of process systems.
  • In addition, they must perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
Requirements
  • A minimum of 3-5 years' experience working in a pharmaceutical or similar GMP environment within a validation, MSAT, or engineering function is required.
  • Experience in commissioning and qualification/validation of facilities, utilities, equipment, and instruments (e.g., bioreactors, chromatography, ultrafiltration, autoclaves, parts washers) is essential.
  • The ability to maintain the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.) is also necessary.
  • Proficiency in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment is required.
  • Equipment vendor package ownership and system design coordination skills are desirable.

This role requires flexibility to take on additional tasks and responsibilities as requested. The successful candidate will act as a role model for the Validation function and the wider organization, adhering to corporate core values.

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