QA Manager - GDP
Our client is a speciality pharmaceutical company focused in clinical supply, unlicensed medicines and international distribution of pharmaceutical products. They are dedicated to helping our customers find cost effective and sustainable solutions and make it easy to source the medicines required. Their international division has expert knowledge of Europe, Middle Eas, Caribbean, Latin America, North America, Far East and Australasia.
They are seeking a QA Manager to joing their team in Hertfordshire, UK. Their Quality Assurance and Regulatory Team ensure they comply with GMP/GDP and FMD.
- Responsible for ensuring the licence provisions are observed and met
- To carry out the duties of the Responsible Person named on the Alium Wholesale Dealer's Authorisation
- Responsible for ensuring that operations do not compromise patient safety and the quality of supplied medicines
- Ensuring that a compliant quality system is established and maintained
- Ensuring audits of the quality system are performed and to carry out independent audits
- Ensuring that adequate resource and capabilities exist within the quality assurance team and that all Alium personnel are trained and developed in line with the requirements of their role.
- Leadership of the quality assurance team and line management of staff, ensuring a high level of team motivation and morale
- Identify risks and to take necessary preventative measures pro-actively
- Hosting and reporting of regulatory inspections, client audits and supplier audits
- Liaise with regulatory authorities (MHRA, Home Office)
- Provide support to all business development opportunities to ensure proposals can be implemented from a compliance perspective
- Mentor peers, serving as a subject matter expert on quality systems, processes and issues.
- Other ad hoc duties as required
Essential Qualifications and Experience:
- Pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy
- Degree in Quality Management life science or related field (desirable)
- Minimum of 10 years of relevant industry experience
- Excellent communication skills: verbal and written
- Proven Leadership capabilities in a senior quality role
- Extensive knowledge of GMP and GDP
- Practical experience in Supply Chain, Production and Quality Assurance
- Experience of hosting MHRA inspections, client audits and self-inspections
- Fully IT literate: Microsoft Outlook, Word, Excel, SAGE (desirable)
- Effective planning, organisational and administrative skills
- Ability to work with cross-functional teams on new process projects, incident investigation, identification of root causes and process improvements
If you are interested in applying, please click the apply button. Please write a short note explaining why you are interested and how you are suitable for the position. If you have difficulties applying or have any questions, please contact Courtney Russell on 0203 8141 315 or upload your CV to 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.
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