Quality Control Manager – Biologics
RoslinCT, is a leading Contract Development and GMP Manufacturing Organisation in the field of Biologics and Regenerative Medicine and looking for a driven individual to join them as a QC Manager.
RoslinCT is an Edinburgh-based company operating at the leading edge of therapeutic discovery and provides services for companies involved in European and US clinical trials. We are looking for an effective leader to lead, motivate and develop the QC team in the ever-evolving field of Precision Medicine.
The company work to the highest standards of quality and customer service and we are looking for an individual who shares in these values. The individual will be responsible for expanding the QC operation, take the department to the next level within a new state of the art facility and be a key contributor in the overall growth of the business.
· To ensure that Production complies with the requirements of Good Manufacturing Practice (GMP).
· To undertake the Quality Control function within the company, ensure that sampling, and testing is performed against set specification in accordance with approved schedules prior to release of any product.
· To Co-ordinate and oversee the environmental/microbiological monitoring of the GMP clean rooms, personnel and processes simulations to ensure compliance with GMP.
· In particular, the post holder will ensure the Quality Control compliance with the applicable HTA and MHRA regulations.
· Lead, motivate and develop Quality Control staff to ensure they deliver on goals and achieve appropriate standards of work.
· Ensure documentation, including SOPs and protocols are in place for all activities performed within Quality Control and these are reviewed regularly
· Ensure incidents or changes are documented and approved in accordance with approved procedures.
· Ensure that equipment and processes used in the Quality Control department are subject to effective validation, and that documentation used is approved.
· Ensure Quality Control equipment is maintained, qualified and Calibrated in accordance with agreed timelines.
· Manage documented procedures for ensuring all raw materials used for manufacturing are checked against agreed specifications and are only released for use after appropriate inspection procedures.
The successful candidate will have:
· Significant experience in a relevant area of activity (e.g. pharmaceutical industry and in a supervisory/managerial role.
· Relevant post graduate degree or equivalent professional qualification
· Demonstrable ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
· A clear understanding of GMP and Quality Control
· Demonstrate competence in reporting and presenting internally/externally (MHRA visits, customer visits)