QA Specialist with GMP

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Job Description

QA Specialist - Project Support - 12 period Fixed Term Contract

Our Client is looking to enlistee a QA Specialist with astatine slightest 5 to 10 years expertise wrong a objective environment.

Reporting to and with the guidance of the Head of Quality Assurance, this relation volition guarantee that the manufacturing centre, via proactive engagement, meets the standards and expectations of 2 cardinal stakeholders; the regulatory authorities and imaginable collaborators.

  • To enactment wrong a multi-disciplinary squad to instrumentality a tactical relation successful the governance and oversight of the enactment associated with delivering beneficial usage to the installation expansion.
  • To enactment arsenic a azygous constituent of interaction for each Quality interactions betwixt the manufacturing centre and third-party contractors liable for delivering the expansion.
  • Participate successful the mentation for and the absorption of regulatory bureau and lawsuit inspections related to the enlargement project.
  • Ensure the PQS is maintained successful a acceptable for intent authorities of power for a multi-purpose, multi-client installation and guarantee consistency betwixt existing processes and procedures and those associated with the extension.
  • Provide wide prime taxable substance expertise to the enlargement task team.
  • Provide compliance enactment by providing proposal and facilitating the escalation of compliance issues done the due routes.
  • Promote the consciousness of prime requirements and enactment the improvement of the prime civilization passim the company.

Experience indispensable see the pursuing skills:

  • Participation successful multidisciplinary task teams with acquisition successful installation and/or cleanroom qualification enactment and successful sterile manufacturing processes, ideally ATMP's oregon biologics.
  • Sound cognition of EMA and FDA regulatory environments and requirements.
  • Familiar with planetary standards related to prime e.g. ISO 9001.
  • Experience moving arsenic a Quality Specialist oregon equivalent successful biologics and preferably cellular and/or cistron therapies.
  • Ability to negociate aggregate and varied tasks and prioritize workload with attraction to detail.
  • Comfortable operating autonomously erstwhile goals and objectives are set.
  • Excellent interpersonal, written and verbal connection skills.
  • Confidence and ambition to supply pragmatic and considered GMP advice.
  • Having existent and up to day nonrecreational knowledge, expertise and champion practice.
  • Proven quality to prosecute constructively with colleagues astatine each levels crossed antithetic departments to present objectives.
  • Ability to rapidly found credibility and physique rapport and trust.
  • A bully squad player, with beardown organisational skills.

Educated to Degree level successful a beingness sciences discipline.

Member of a nonrecreational organisation e.g. RSC, SOB, CQI etc. (Desirable).

The Client is based successful Stevenage Hertfordshire.

The wage for this presumption is successful the scope £45K - £50K.

Please nonstop your CV to america successful Word format on with your wage and availability.