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Principal QA Officer, Automation and Computerised Systems

Date: 16-Jun-2022

Location: Oxford, GB

Company: oxfordbiom

Do you pride yourself on your integrity? We do what’s right for employees, patients and partners, and so can you.

 

Oxford Biomedica’s Quality Assurance (QA) team is responsible for the company’s quality processes and systems, in compliance with GMP, GLP and GCP guidelines.  The team are accountable for internal and external audits, quality compliance and control.

 

We have a new specialist opportunity to join our QA team to focus on the implementation of new technologies with high levels of automation in GMP manufacturing processes.

 

Your responsibilities in this role would be:

  • Provides subject matter expertise (SME) in relation to QA compliance to impact the design and implementation of a range of new technologies with a key focus on automated technologies.
  • Collaborate with the MSAT and Manufacturing Departments to introduce new and innovative technologies into the manufacturing processes
  • Collaborate with the Validation Department to develop Validation approaches for projects and review facility / equipment qualification documentation
  • Create strategy documents, technical reports and procedures for new Quality processes involved in projects
  • Lead Quality related risk assessments for projects
  • Review and approve project generated policies and procedures
  • Provide handover training and on-going support for QA Operations
  • Provide Quality Technical SME input to investigate problems in conjunction with Manufacturing / Analytics and other subject matter experts to determine corrective and preventive actions
  • Provide direct quality team support during customer and regulatory audits
  • Review quality systems documentation including Deviations, Change Controls and CAPA’s.

 

To be successful in this role, you will have the following skills and experience:

  • Educated to degree level in a life sciences subject or possess significant industry experience.
  • Extensive experience and subject matter expertise in the Quality Assurance activities associated with automation or computerised systems
  • Extensive working knowledge of GMP, GAMP & Quality related pharmaceutical regulations & standards
  • Experience of direct interaction with Regulatory Bodies (e.g. MHRA, HPRA, FDA).
  • Expert user of quality risk management tools in ICH Q9
  • Experience of having worked in a sterile Manufacturing environment preferable.
  • Experience of isolator technology or similar barrier technologies desirable
  • Extensive experience in authoring and reviewing the full range of QMS documentation.
  • Excellent spoken English communication skills able to deliver concise information to both internal and external key stakeholders

 

 

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

 

Collaborate. Contribute. Change lives

 

No agencies please.