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Quality Assurance Manager - United Kingdom
Kyowa Kirin (company)
Posted on : 07 May 2017
- Our company is going through an exceptional time.
- With three product launches expected over the next three years and further new product development combined with excellent international growth rates, we are providing a great platform for today and our future.
- The strength behind our success and future opportunities are our highly committed and skilled staff, supported by our parent , whose substantial reinvestment into R&D is creating products at both early and late stage development.
- This prosperous time at our company includes developing new teams, new departments and moving into exciting new areas
Quality Assurance Manager
Provide QA support for the manufacture of company’s products to ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorizations, company operating policies and procedures and business requirements.
- Participate in the project management meetings to keep abreast of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance
- Prepare and maintain Technical Agreements with third party CMOs
- Ensure that an appropriate level of product batch record reviews are carried out
- Regularly review non-conformances
- Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO and company change control processes
- Carry out a review and approval of validation protocols and reports during Technical Transfer and process change activities
- Ensure that an appropriate response has been provided by the CMO following investigation into customer complaints
- Ensure that Product Quality Reviews have been carried out and reported by our CMOs
- Ensure that GMP stability programmes are established, implemented and regular reports issued by CMOs
- Minimum Life Science degree
- Broad pharmaceutical industry experience with several years operating in a senior QA Management position at a manufacturing site
- At least 3-5 year experience working in a QA Specialist Role related to different types of pharmaceutical formulation types
- Strong people management ability, having previously lead a team
- Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements
- Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes
- Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids
- Familiar with the regulatory requirements for validation activities
- Pension scheme
- Private medical insurance
- Other voluntary benefits include: Childcare Vouchers, Bike to Work