QA Lead | Pharmaceutical industry
Ceredigion | Permanent
- Provide the leadership for the core quality system processes in parallel with other stream leads to ensure effective management of the Quality System.
- Ensure that departmental objectives are implemented in line with the overall Quality /Corporate goals. The key quality processes to be led include customer complaints, change control and quality event I CAPA processes, self-inspection programme and batch release.
- Ensure compliance to the global Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
- Review and approve validation lifecycle documents to support adherence to the SVMP and project activities.
- Ensure effective coordination of the self-inspection programme and ensure timely completion of audits and audit actions.
- Ensure all activities required for the disposition of finished product by Qualified Person including effective coordination of batch release activities between operations/manufacturing, batch release team and the QP.
SKILLS AND EXPERIENCE…
- Degree in science discipline (chemistry, biology or medical technology preferred).
- Quality qualification, e.g. CQI Diploma in Quality (or demonstration of satisfactory experience within QA department)
- Experience leading a QA Team
- Experience in a drug manufacturing, medical device or biologics industry in Quality Assurance, Quality Control or Quality Engineering position.
- Knowledge of document control systems
- Experience with internal and external audit processes
- Join a supportive, and inclusive work culture
- Work in a fast-paced, exciting environment
- Private healthcare and other benefits
- Bonus scheme