Quality System Specialist

• Feb 2022 - Present

Helping keep the NHS and multiple healthcare (UK and globally) stay disinfected against those nasty viruses and bugs with cutting edge chemistry Helping keep the NHS and multiple healthcare (UK and globally) stay disinfected against those nasty viruses and bugs with cutting edge chemistry

Process Quality Specialist

• Dec 2018 - Feb 2022

Operational QA Operational QA

QA Engineer

• Jul 2018 - Dec 2018

Lead QA Engineer

• Jan 2016 - Jul 2018

Exception Report Investigation Team Leader

• May 2012 - Dec 2015

• Managing the CAPA process and the ER Investigation team to ensure that ERs (Exception Reports) are initiated and investigated in a timely manner to root cause meeting corporate and divisional requirements. • Providing a dynamic and effective stewardship of Witney’s CAPA system. Partnering subject matter experts to ensure delivery of results that support and safeguard Quality at ADC Witney• Supporting the determination and implementation of actions to reduce the occurrence/reoccurrence of non-conformance.• Providing QA direction and approval of ERs. Collate and report agreed Quality metrics to management and EMR/SMR (Executive & Site Management Review)• Working with other functions to promptly identify the impact and ensure that any affected components or products are identified and contained. Ensuring that potentially serious Quality related issues are promptly communicated to QA Manager, QA Director and Senior Site Management.• Supporting audit readiness for internal and external Quality Systems audits and taking a lead in interfacing with external auditors during inspections/audits wrt CAPA

Quality Engineer

• Jul 2003 - May 2012

• Unit QA Engineer responsible for ensuring that manufacturing plant, people and processes are compliant, that product manufactured is safe and efficacious and site is in a constant state of audit readiness.•Deployment and fostering of general Quality/Compliance/GMP educational training •Make quality decision on product during product manufacture and being one of the prime quality members present outside normal working hours and Quality signatory for process review changes ie Dev Trials.•Implementing resolutions to improve the quality of the product and process.•Initiation (+ all that ensues for when non-conformances occur), Investigation plus independent review and Approval of Exception Reports (ERs), CAs, Effectivity checks and confirmation of corrections and trained as a member of the CAPA Review Board.•Approver of documentation changes for various stages of the documentation process.•Review and approval of on-line corrections and reworks and performing post rework verifications.

Purification Scientist

• Jan 2002 - Jul 2003

• Part of Process Driven team that is responsible for purification of monoclonal antibodies and recombinant proteins to cGMP. This involves every process from when unpurified product is transferred to purification through to the product batch release. • Assisted validation department with performing their OQ/PQ validation protocols for new bioprocessors. • Completion of cGMP batch records (including licensed products) and progression of deviations for non-conformances. • Asceptic way of working • FDA compliant

First Line Shift Manager – Oral Care Manufacturing

• 2000 - 2002

• Responsible for schedule adherence of product to line utilising operators/technicians and facilities (~7million units per week) • Ensuring that the facility was compliant in readiness for internal and external auditing. Ensuring that facility was maintained to GMP standard using 5s principles and that the facility was a safe environment via DOs, Risk and COSHH assessments • Arranging and driving sanitisations of mixers, storages and intermediate vessels in compliance with microbiology department. • Ensuring departmental staff were fully trained to complete their daily tasks • Championing change to Right First Time, Batch cycle times and wastage reduction • Appraisals of staff