Kyowa Kirin have an excellent opportunity for a QA Product Specialist to join our Head Office team in Galashiels.
This role will provide QA Support for the manufacture of Kyowa Kirin's products in order to ensure that each product is manufactured and supplied to the marketplace in compliance with cGMP requirements, Marketing Authorisations, company operating policies and procedures and business requirements.
- Represent QA at Project Management meetings, identifying and addressing any gaps relating to product quality and GMP Compliance
- Prepare and maintain Technical (Quality) Agreements with third party contractor manufacturing organisations (CMOs)
- Ensure that an appropriate level of product batch record reviews are carried out at the CMO facilities and within Kyowa Kirin International
- Regularly review non-conformances e.g. process deviations, out of specification/trend results etc. at the CMO
- Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO and Kyowa Kirin International change control processes in order to maintain GMP and regulatory compliance
- 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 and that corrective and/or preventative actions have been implemented
- Ensure that Product Quality Reviews have been carried out and reported by the CMO(s)
- Ensure that GMP stability programmes are established, implemented and regular reports issued by the CMO(s)
- For each product, maintain a Product Quality Profile, as registered with the regulatory authorities, and provide to the CMO's Qualified Person (QP) so that product can be manufactured, controlled and released in compliance with the Marketing Authorisation
- Take responsibility for one or more of the Quality System(s) - (Documentation Control, Change Control, Customer Complaints, Auditing, Training, Invoice Processing etc), when required, ensuring that personnel are suitably trained, that processes are operating effectively and that the system is regularly reviewed and improved, as necessary
- Review departmental standard operating procedures (SOPs) for content and compliance with the appropriate regulatory requirements
- Participate in the internal audit (self-inspection) programme so that any gaps and deviations identified in systems and procedures are addressed by the relevant department and corrective actions followed up within reasonable time scales
- Carry out staff training, including refresher training, in GxP activities, as necessary, to ensure that staff are kept abreast of current GxP regulations
- Provide regular reports of key performance indicators to QA management
- Participate in the review and recall of defective product, as necessary, in order to minimise patient risk
This role would suit an experienced QA professional who has proven experience of managing Quality Assurance at a pharmaceutical manufacturing site.
To be successful in this role you will require the following:
- Life Science degree or equivalent
- Broad experience of working within the pharmaceutical industry in a QA capacity
- Excellent working knowledge of international GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
- Sound knowledge of the principles of solid and semi-solid dosage manufacturing processes (tablets, capsules, gels, creams, ointments)
- Sound knowledge of QC and Stability chemical analytical testing techniques for solids and semi solids
- Familiarity with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems
- Familiarity with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines
- Familiarity with Quality Management Systems e.g. ICH Q10
- Competitive salary
- Pension scheme
- Private medical insurance
- Relocation support if required
You will be based at our Head Office in Galashiels, commutable from Edinburgh in less than an hour.
Situated in the beautiful Scottish Borders, the local area provides affordable housing options with great infrastructure in terms of schooling, outdoor activities and transport.
This position will also involve international travel.
Kyowa Kirin International is going through an exceptional time. With our imminent rare disease product launches 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 company Kyowa Hakko Kirin - a Japanese Specialty Pharmaceutical company, whose substantial reinvestment into R&D is creating products at both early and late stage development. This prosperous time at Kyowa Kirin includes developing new teams, new departments and moving into exciting new areas.
Kyowa Kirin International is an equal opportunities employer.