Quality Assurance Specialist – UK

Competitive Hybrid

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Job Description

This position will have an impact across Ori Biotech and requires the right person to work across various functional teams as Ori heads towards launching different products. You will be responsible for the implementation and development of a QMS with the Quality manager. The role will participate in the management of suppliers, facilitating and participating in internal and external audits. Additionally, the role requires to provide training, management of documentation and deputise for Quality Manager in engaging with various clients.

Hybrid – London, Cambridge & Remote working

Key Responsibilities

  • Working with the Quality Manager and various functions in implementing the QMS.
  • To author, review and approve various quality systems procedures.
  • Management of Technical File and Master File for OriBiotech Platform.
  • Assisting during meetings with the Regulators and Customers.
  • Working with Quality Manager and assist as an auditor during supplier audits.
  • Supporting ongoing management of suppliers within Quality Management Systems.
  • Driving continuous improvements within the business.
  • To provide needed quality training to Ori employees.
  • To review validation and stability protocols and DHF batch documentation records for Ori Biotech products.

Experience

What would convince us:

  • Previous experience working to GMP standards
  • Good communication and writing skills.
  • Self-starter and driven to learn quality and regulatory.
  • Experience of author new and / or existing company procedures and SOPs
  • Willing to travel, if required by the business.

Benefits:

  • Competitive Salary
  • Benefits package, including a pension scheme and private medical insurance

Contact Type: Full-time, Permanent