QC Specialist

QC Specialist
  • Competitive
  • Permanent
  • Cambridge, Cambridgeshire, England, UK cb2 3ar Cambridge Cambridgeshire UK cb2 3ar
Job Ref: J2157459
Sector: Science
Sub-sectors: Biotech/Life Sciences, Pharmaceuticals, Medical Devices
Date Added: 14 October 2020
Quality Assurance Specialist Hertfordshire Permanent £ Competitive salary and benefits package

Quality Assurance Specialist



£ Competitive salary and benefits package

Scope of role:

Responsible for the development and maintenance of a Quality Management System at a busy and collaborative production site for gene and cell therapeutics. You will assist in the development of internal measures and requirements of the governing bodies, to ensure a consistent and structured method of tracking all quality documentation.

Role requirements:

  • Acting as primary point of contact for both internal stakeholders and associates based on site
  • Strategic development of the QMS, suggesting improvements as necessary and taking feedback about the user-interface
  • Regular interaction with the regulatory bodies, development of governance structures particular to cell and gene therapy/manufacturing
  • Prepare for regulatory agency and client inspections
  • Act as Quality SME for the busy site
  • Signpost internal staff and associates to best practice Quality behaviours
  • Take part in the GMP internal audit programme - including corrective actions, and remedial actions to ensure quality improvements are met

Person specification:

  • Your background will include working in Quality in aseptic manufacturing environments (ideally biologics, but other areas can be considered)
  • Proven background of building and establishing GMP based quality systems
  • It would be helpful to have worked in an R&D setting, ideally with regulatory authorities such as FDA and EMA, and a good awareness of ISO 9001.
  • Highly motivated and team-spirited, comfortable working autonomously, working to deadlines and owning project management and outcomes

Does this sound like it could be the ideal next step for you?

Do you have a proven Quality management background?

Do you come from a biologics, pharma or medical device background?

Contact Bec Johnston: bec.johnston@srgtalent.com / 01223 607858

13/11/2020 14:07:34
Contact Consultant:
Bec Johnston2

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