Description
Day to day responsibilities:- Leading batch assessment and release activities to ensure releases are carried out efficiently, in a timely manner, and meeting relevant regulatory standards.
- Performing duties of the Qualified Person in compliance with all applicable EU GMP regulations and directives.
- To improve quality, facilitate Quality management and lead the development of a right first time, quality culture.
- Conduct audits of third parties suppliers and service providers.
- To manage Quality Incident report investigations and implement CAPA as necessary.
- To write Standard Operating Procedures, approve production operating manuals, and maintain updated Standard Operating Procedures.
- To be responsible for GMP training.
- To continue to develop the skills of the Quality Assurance team.
Requirements:
- 8+ years experience Previous Sterile Manufacturing experience.
- Life Sciences Degree.
- Eligible as a Qualified Person.
- Relevant experience within a Pharmaceutical Quality Assurance / GMP background.
- Knowledge of process improvement techniques an advantage.
This is an urgent position with a strong possibility of an extension on the contract. If you would like to apply please contact Sarah Irvine on or reply with a copy of your current CV.
Alternatively if you know of anyone who may be suitable for this position feel free to get in touch as we offer shopping vouchers for any successful referrals.