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  • Location: Edinburgh
  • Salary: Competitive Salary plus benefits
  • Job Type:Permanent

Posted 18 days ago

  • Sector: Quality
  • Contact: Adrienn Prezenszki
  • Contact Email: adrienn.prezenszki@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2022-06-14
  • Job Ref: 1838-55308497
Are you an experienced individual within GMP Manufacturing and looking for a role within Quality Assurance? or Are you an experienced QA Officer in a GMP environment?
 
If so, there are 2 x newly created permanent opportunity available for QA Officers to become a key member of the Quality Assurance team and undertake a range of activities in the maintenance of the Quality Management System.
 
The company is creating cutting – edge therapies to help change people’s lives in their state-of-the-art GMP manufacturing facility in Edinburgh.
 
The Role:
You will be responsible for using your GMP background and knowledge to carry out activities to maintain the QMS.  
 
Key Responsibilities:
  • Reviewing, writing and updating SOPs, batch records and production material specifications to ensure compliance with company policies, practices and relevant standards and guidelines.
  • Writing, implementing, reviewing and maintaining SOPs, policies and other documentation for QA activities.
  • Administration, review and approval of key QMS documents including incident reports, change controls, CAPAs and risk assessments.
  • Performing data review audits including batch records, validation documents, development documents and QC data. 
  • Performing and reviewing internal and external audits to determine compliance with GMP and identification of areas for improvement.
  • Issuing, reviewing and closing Corrective and Preventative Actions (CAPAs).
  • Reviewing and approving suppliers/service providers including supporting with audits of critical suppliers where required.
  • Supporting the Quality Assurance Supervisors and Managers with hosting customer audits and regulatory inspections.
  • Compiling quality metrics to facilitate monitoring of the company’s quality systems.
 
Experience:
  • You will have a Life Science degree and 2 – 3 years’ experience working within a GMP manufacturing environment within a pharmaceutical or biopharmaceutical company working with biologics etc. or 1 – 2 years’ experience in a Quality role.
  • You would ideally have experience working with quality management systems and compliant with FDA, UK, EU regulations
  • You would need to have some experience in report writing and customer visits or audits
  • You need to have strong attention to detail and excellent communication skills