Background: Quay Pharmaceuticals is a fast growing, contract pharmaceutical development company working with clients globally to develop new pharmaceutical and biotechnology products for a wide variety of disease indications in both adults and children. It is a privately owned company, established in 2002 and now employs approximately 155 people.
We are an entrepreneurial company and encourage our employees to help us shape and become the future of our company.
Role: As a QA Validation Officer you will be part of the Quality Assurance department responsible for ensuring GMP is followed for all validation activities. The role will focus on the validation and qualification of production and laboratory equipment and processes.
- Understanding of quality management systems (i.e. Change Control, Deviation)
- Experience of working within a GMP environment
- Experience of use and qualification of analytical and production equipment would be beneficial
- Ability to work to tight timelines
- Ability to work unsupervised.
- Minimum BSc HONS Degree (or similar) in a science related discipline
- Strong communication and interpersonal skills.
- Demonstrate good organisational skills, have an eye for both technical detail, numbers and be fluent in the use of Word and Excel. Other systems can be taught.
Importance will also be placed on the attitude, enthusiasm and interaction that the candidate demonstrates during the interview.
Reporting into the Validation Manager, day to day activities will include the following:
- Preparation and execution of validation life cycle documentation
- Ensure all validation activities are carried out in accordance with GMP
- Ensure all processes, equipment and facilities across the site are validated and re-qualified in accordance with the validation matrix and GMP
- Liaise with various departments involved in the validation work to ensure efficient performance of the related tasks
- Provide support to new projects
- Assist in the investigation of problems and provide support to the business in resolving quality issues
- Ensure that all documentation is prepared, authorised and completed in a timely manner
- Ensure that the section has adequate health and safety procedures and that these are reviewed and updated on a regular basis
- Manage and maintain validation documentation archive
- Support the product introduction teams in managing deviations and investigations to ensure no impact on project timelines
NO AGENCIES PLEASE