QA Technical Specialist

QA Technical Specialist

Speke

Pioneer a ‘new’ Quality way

As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.

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.

Provide technical support to realise lean, compliant solutions based upon data, technical understanding and regulatory intelligence; enhancing capabilities and compliance.

Experience in supplier management, change control governance and quality risk management is preferable, as well as validation lifecycle/documentation, GMP/license compliance and self-inspection/regulatory audits.

We are looking for candidates with a keen interest in application of lean tools and establishment/maturity of business processes to drive lean, compliant delivery of operations; supporting introduction of digital solutions and working inclusively and collaboratively across the site functions.

Essential for the role

• Degree in a relevant subject or the equivalent in experience

• Proven pharmaceutical industry experience in manufacturing, QC, or QA validation of biologics

• Established QA technical expertise

• Membership of a professional body eg ISPE, PDA, IOB, RSC etc

• Broad understanding and up to date knowledge of cGMP regulation and guidelines

• Knowledge and understanding of Quality systems such as Qualification/Validation, Change Management and Quality Risk Management

So, what’s next…

Are you already imagining yourself in this role? Good, because we can’t wait to hear from you!