Quality Control Manager Job in Llandysul, Wales UK
Quality Control Manager
My client is an international biopharmaceutical company with operations in Europe, North America, Australia and Japan; this is an opportunity to join an industry leader at an exciting time in their 30 year history.
They are seeking a Quality Control Manager, this pivotal role will be instrumental in supporting their anticipated growth. This position is a permanent post based in Ceredigion, Wales.
Reporting to the Corporate Head of Quality the successful applicant will have responsibility for
all operational and product development aspects of Quality Control (QC) in addition to supporting the wider Quality function.
Key Duties
• Manage the QC sampling and testing of raw materials, equipment, facilities, process
intermediates and finished products such that results are generated in a timely manner
according to established written procedures and GMP.
• Generate and review on an ongoing basis the validity of specifications for sampling and
testing in accordance with current regulatory requirements.
• Co-ordinate assay transfer from other departments/organisations and any validation
undertaken by the QC department.
• Manage the investigation and documentation of out of specification results and incidents /
deviations generated within the QC department.
• Provide training to QC personnel and support their professional development.
• Manage the general laboratory functions so as to maintain efficient working practices.
• Assist with internal and external GMP auditing when required.
• Keep updated with current technology and regulatory changes.
• Ensure that the QC department performs all tasks in accordance with Health and Safety
procedures as laid down by the company.
• Approve and monitor the contract test facilities.
• Support and perform in accordance with the Company Values at all time. Positively
communicate and ensure these values are instilled within the QC team.
• Carry out other reasonable tasks as required by the Head of Quality.
Candidate Requirements
• Degree in a life science, ideally membership of an appropriate Professional Body.
• Extensive experience working in the Pharmaceutical or related industry with a working
knowledge of the requirements of the MHRA and FDA essential and experience of biological
products desirable.
• Qualified Person / eligibility for registration as a Qualified Person desirable.
• Proven people management and leadership skills.
• A confident communicator with excellent interpersonal skills.
• An effective planner able to motivate others and dynamically manage a team.
• A competent, highly organised individual who pays attention to detail.