Quality Manager - GMP Manufacturing
External
Sartorius · Glasgow, UKPrepare for this interview
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Join our team at our Newhouse facility as Quality Manager. We are looking for a Quality Manager for our Cell Bank Manufacturing department at Sartorius Stedim BioOutsource Ltd. In this role, you will be responsible for managing a team of Quality Assurance and Quality Control Specialists, oversee customer and regulatory audits, be QC named responsible person to maintain our MHRA license, overseeing batch release of GMP batches, work closely with our QP to ensure compliance with regulatory requirements. You will manage a team of 7 and we are looking forward to shaping the future with you. This position is available full time on a permanent basis. It is an onsite role, based at our Newhouse site near Motherwell. Grow with us - Your Responsibilities Maintain and continuously improve our Quality Management System (DotCompliance), monitoring KPIs and reporting to management on a regular basis Approve equipment and facility qualification, validation and maintenance in accordance with appropriate regulatory and usage requirements Assess, inspect (where required) and approve suppliers/contractors to ensure they meet the company's and Regulatory Authority compliance, technical and service requirements Lead client and Regulatory inspections, and co - ordinate any observations to ensure that they are adequately addressed Prepare and review Quality Agreements with clients defining responsibilities of the Contract Giver and Acceptor in terms of Quality and compliance requirements Review and approve all master batch related documents and co - ordinate release of cell banks with Qualified Person Respond to customer complaints putting in containment actions, full analysis, and implementing short-term and long-term countermeasures. Ensure compliance with GMP regulations What will convince us Master's degree in Biology, Biopharmaceutical, Biotechnology, Pharmaceutical Manufacturing, Quality or relevant disciplines 5+ years of experience in the pharmaceutical or biotechnology industry ideally in GMP manufacturing environment Experience with sterile manufacturing and batch release would be beneficial Experience of hosting audits (MHRA, FDA) Strong leadership skills, experience of managing a team with the ability to build relationships with internal and external stakeholders Experience of maintaining the Quality Management System Excellent communication and presentation skills, as well as strong project management and organisational skills Excellent skills in Microsoft packages such as Word, Excel In order to commence working with us, the successful candidate must have the right to work in the UK.
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