Quality Assurance Lead - Llandysul, United Kingdom - Sunny

Sunny

Verified Company

Llandysul, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Bio-Pharmaceutical industry

QA Lead | Pharmaceutical industry

Ceredigion | Permanent

THE POSITION

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, selfinspection 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 selfinspection 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

BENEFITS.