Senior Biotech Quality Assurance Manager

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €2,800 - €5,600

Biotechnology Quality Assurance Specialist

Overview:

This role is responsible for providing quality assurance oversight of a contract laboratory, CMO or a raw material SRE. The successful candidate will be an integral part of a cross-functional team that includes business operations, analytical science, process development, and supply chain.

  • Lead the preparation of the site for and represent the company at product-specific regulatory inspections and/or during notified body audits of the CM Site, as applicable or required.
  • Review and approve master batch records, deviations, change controls, CAPA and QAGR.
  • Prepare inspection playbooks and identify and mitigate risk at the CMO or testing laboratories.
  • Perform person in plant activities as required and manage audit commitments to completion.
  • Make decisions on batch disposition, approval or rejection of deviations, change controls, CAPA and QAGR.

Requirements:

The ideal candidate will have a doctorate degree and 2 years of directly related experience, or a master's degree and 4 years of directly related experience, or a bachelor's degree and 6 years of directly related experience. Alternatively, they will have 10+ years of biotech or pharmaceutical industry experience.

Additional European languages are desirable but not essential. Significant quality experience at aseptic manufacturing facilities is also required.

Key Responsibilities:

• Provide quality assurance oversight of a contract laboratory, CMO or a raw material SRE

• Lead the preparation of the site for and represent the company at product-specific regulatory inspections and/or during notified body audits of the CM Site

• Review and approve master batch records, deviations, change controls, CAPA and QAGR

• Prepare inspection playbooks and identify and mitigate risk at the CMO or testing laboratories

• Perform person in plant activities as required and manage audit commitments to completion

• Make decisions on batch disposition, approval or rejection of deviations, change controls, CAPA and QAGR

Package:

Contract role - hourly rate €60-€70 per hour. Minimum 12-month contract.

Onsite expectations: fully remote. There may be occasional requirements to go on-site in Dun Laoghaire as the team is aligned to this location.

Travel: we do not foresee a huge amount of travel but it is worth flagging, extending to Europe.

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