- Support start-up activities from a quality aspect to ensure compliance
- Support all quality and compliance requirements for the Biologics Integrated Process Team (IPT) to enable batch disposition for each batch manufactured.
- Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
- Coordinates the work of others within the team
- Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
- Active member/Lead (as required) within the cross functional IPT team providing quality expertise, support and advice to the IPT team on Quality Assurance and GMP compliance aspects.
- Works within IPT to ensure supply of high quality product through implementation and oversight of the Quality Management System.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
- Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
- Liaises with Corporate Quality to ensure alignment on actions related to Quality Systems and/or Operational Quality at the site.
- Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
- At least 5 years' experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes a minimum of 2 years' experience in a Quality Assurance/Quality Operations function.
- Degree in Science, Engineering or similar
- Green belt or suitable alternative (desirable).
- Good communication & interpersonal skills.
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The Life Science Specialists