Opportunities for permanent roles in a range of business sectors

Quality Assurance Advisor

We are looking for a conscientious and articulate Quality Assurance Professional with a proven track record in a cross functional cGMP/GCP/GLP environment, to join us on a permanent basis.

Key responsibilities and accountabilities:

  • Demonstrates a strong knowledge of root cause analysis techniques
  • Able to plan, carry out and follow up on audits/self inspections
  • Able to perform QA audits/data pack review including those relating to CSV and Validation activities
  • Support and administration of system relating to equipment qualification
  • Audits and approves protocols and reports related to equipment Validation including CSV. This includes review of deviations reported during execution
  • Maintain knowledge in the current and relevant regulations and guidance in accordance with role demands and changes
  • Support external inspections, customer audits & enquiries as required
  • Work productively and dynamically with QA/CSV/Operations teams

Education, experience and technical skills:

  • Degree in a Scientific discipline
  • Minimum of 3-5 years of experience in Pharmaceutical, Biotech,  or Medical Devices
  • Familiarity with related GMP/GCP/GLP procedures and requirements
  • Knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks
  • Proven track record in Quality Assurance with a focus on document audits
  • Experience within Quality Control or GCP/GLP testing facilities would be a distinct advantage
  • General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical laboratory environment would be a distinct advantage 

Essential competencies and behaviours:

  • Ability to work independently and as part of a team
  • Ability to communicate effectively with all areas of the business, including scientific and management groups
  • Able to contribute towards process improvement activities within regulatory and legal frameworks
  • Able to demonstrate an analytical and meticulous approach to tasks