ProClinical is seeking a Validation Specialist on behalf of our client, a small pharmaceutical company based in the UK, to join their team in the West Midlands on a permanent basis. The QA Officer will work in the Quality & EHS department as part of our manufacturing facility, producing cGMP-compliant biopharmaceuticals.
- The key function of this position is to ensure that all international validation requirements are applied and maintained throughout the manufacturing facility.
- It is vital, in order to assure the safety of company products and maintain compliance status, that all quality-impacting activities are validated in an industry best practice manner.You will be challenged with the complexity of establishing and maintaining a good working knowledge of current and historic validation activities for assigned systems and processes within a state-of-the-art automated manufacturing process that is run on a 24/7 operational basis.
- You will also learn to plan, resource and manage tasks effectively whilst having the opportunity to gain in-depth knowledge of cGMP biotech manufacturing. These tasks will include preparing, generating, executing and reviewing qualification protocols, writing validation reports, defining appropriate acceptance criteria, scheduling validation activities and validation equipment availability, investigating and closing discrepancies and deviations, providing training in validation activities and acting as the validation expert in customer and regulatory audits.
- The role entails working as part of a multi-disciplinary team that has close interaction with all other departments within the company
Qualifications, Skills and Experience:
- You should be qualified to a minimum of degree level in chemical sciences or biochemical/chemical engineering and/or have at least three years' experience of validation in the pharmaceutical industry
- Able to demonstrate an ability to work according to detailed written procedures and in a systematic manner.
- The ideal candidate will possess good team, interpersonal and communication skills together with the ability to organise and manage their own workload, often to tight deadlines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies