To be a single point of contact with key contract customers for quality related interaction
- Technical agreements
- Change control
- Audit scheduling.
- Support the on-going implementation and operation of key quality systems and act as voice of the customer.
- Management of technical agreements, ensuring technical agreements are managed and approved in a timely manner and that the requirements of technical agreements are incorporated into the company quality management system.
- Providing communication to contract customers and contract givers on changes.
- Informing contract givers and license holders of changes instigated by the company and ensuring license changes and customer requests are fed into the company Change control
- Data analysis - taking data and reporting and presenting it to provide information and in site to the restro of the QA team and wider organisation
- Coordinating preparation for customer and 3rd party audits
- Collating quality data for customer specific reports and communicating quality performance with customers
- Coordinate with purchasing on supplier quality management
- Providing support for other team members in management of key quality system processes
- Demonstrate knowledge of pharmaceutical legislation and a good understanding of GMP.
- Compliance based focus – performance against regulations and reasonable customer expectations, corporate and internal standards.
- GCSE pass or equivalent in Maths, English and a Scientific subject. Ideally can speak a second language.
- Good report writing skills.
- Effective communication – written and verbal – can convey information positively, succinctly, objectively.
- Must be proficient in computer software programmes such as word and able to manipulate and present data using pivot tables, charts and lookup.
- Proactively identifies gaps, issues, and opportunities for improvement, offers solutions and works with colleagues to collate, review and implement the best plan.