Quality Assurance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €79,230 - €108,490
Job Description

We are seeking a highly skilled Quality Assurance (QA) professional to join our team in a challenging and rewarding role.

This position involves quality oversight of validation activities in a regulated environment, ensuring that products meet the highest standards of quality and safety.

The successful candidate will have a strong background in cGMP regulations, with experience in equipment and utility validation, laboratory systems/validation, and project management.

They will also be able to communicate effectively with cross-functional teams, including engineering, manufacturing, and quality assurance, to ensure seamless execution of projects.

Responsibilities will include:

  • Providing quality oversight for FUE activities related to product development and manufacturing.
  • Developing and implementing validation plans for specific system implementation projects.
  • Reviewing and approving project lifecycle documentation, including URS, RA, Commissioning, and Qualification Protocols.
  • Establishing site validation policies through development, generation, and implementation of validation master plans, guideline documents, and SOPs.
  • Maintaining current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin.

Requirements for this role include:

  • Bachelor of Sciences degree in a technical discipline required.
  • +3 years' experience in a cGMP regulated manufacturing environment with knowledge of equipment and utility validation, and laboratory systems/validation.
  • Strong organizational and management skills to coordinate multi-discipline project groups.
  • Ability to communicate effectively with audiences and inspectors.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.

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