Quality GMP Assurance Specialist

Proclinical is working with a biopharmaceutical company that is dedicated to extending and improving lives of patients with haematological cancers. This biopharmaceutical company is seeking a Quality GMP Assurance Specialist to be based in the UK on a contract basis.

Job Responsibilities:

• Oversee, support and follow up investigations of all non-conformances.
• Ensure that cGMP requirements and quality standards are recognized, understood and implemented across the company.
• Work cross-functional to implement any updates that may impact the development program(s).
• Support the preparation, performance and support of regulatory inspections.
• Maintain status of vendor and supplier qualification.
• Assisting and maintaining the quality management systems, including an electronic document handling system in the company.
• Provide quality oversight at global CMOs, ensuring products and activities are GMP compliant for biological product.
• Create, review and approve quality related documents - specifications, master batch records, protocols, reports and other quality documents from the CMOs.
• Experience with analytical QA activities including specifications and managing OOS's.
• Perform internal and external audit and ensure appropriate corrective action preventative action plans (CAPAs) are implemented to ensure compliance with standard operating procedures (SOPs), regulations, and best practices.

Skills and Requirements:

• Minimum 15 years of GMP/QA experience, including comprehensive knowledge of EU and US GxP regulations.
• GMP/QA experience with biological manufacture is essential.
• Experience with analytical QA.
• Experience with regulatory inspections.
• Experience with working with contract manufacturing organisations (CMOs).
• Experience with QMS activities - implementing and managing QMS systems, handling deviations, change controls and OOS.
• Experience with regulatory inspections.
• Highly-organized, efficient and with an excellent attention to detail.
• Experienced in executing supplier audits and/or internal audits.
• Experience with an electronic document handling system is an advantage.
• Excellent communication skills, with a high proficiency in English, written and spoken.

To Apply:

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.