An exciting and challenging opportunity has arisen for a QC Manager within a leading Contract Development and GMP Manufacturing Organisation in the ever-evolving field of Biologics and Regenerative Medicine.
As a commercially structured operation, the company displays considerable ambition in both leading the market and in building an effective physical model to meet the demand that is envisaged. This Edinburgh-based company operates at the leading edge of therapeutic discovery providing services for companies involved in European and US clinical trials.
The opportunity has arisen within the company’s management team for an experienced Quality Control Manager. Initially Reporting to the CEO, 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 must have a sound scientific knowledge of cell biology/biologics in order to expand the QC operation and take the department to the next level within a new state of the art facility.
- 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)
• Competent in computer packages including Microsoft Office and an electronic quality management package