Job Description
We are a team of ambitious people, who want to go far, and we’re all here to achieve. It’s what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes. We now have an opportunity to join our team as a QA Technical Specialist. Working at our biologics site in Speke, reporting into the Quality Technical Manager; you will support functions across research, development, quality control, engineering, manufacturing and supply chain. You will be part of the Quality Technical team delivering the Quality Strategy and Goals; realising solutions based on data, risk and regulatory compliance. What you’ll do Provide expertise across Quality processes supporting operations at the Speke Site, including Equipment/Material/Method/Process/Product Introduction, Supplier and Site Change, Major GMP/License deviation investigations, Risk Management, Regulatory Governance/Compliance and Quality Risk Management/Control Strategy Application.
Responsibilities + Skills
Education
Degree in a relevant subject or the equivalent in experienceProven pharmaceutical industry experience in manufacturing, QC, or QA validation of biologicsEstablished QA technical expertiseMembership of a professional body eg ISPE, PDA, IOB, RSC etcBroad understanding and up to date knowledge of cGMP regulation and guidelines
Experience
