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We are currently looking for a Quality Lead and Qualified Person to join a leading, international biopharmaceutical company based in the Wiltshire area. As the Quality Lead, QP you will be responsible for the development and maintenance of the Quality Systems whilst also ensuring commercial batches have been manufactured in accordance with the requirements of the marketing authorisation.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Head of Quality, QP will be varied however the key duties and responsibilities are as follows:
1. You will manage the Quality Assurance department including the Quality System and procedures, ensuring consistency with industry and company regulations. You will deliver continuous improvements within all areas of the business, to enhance the quality culture.
2. You will liaise and interact positively with appropriate regulatory authorities to ensure company compliance as well as promoting and upholding the highest standards of professionalism in order to create, maintain and enhance the reputation of the business, division and wider company amongst its customers and stakeholders both nationally and internationally.
3. As the Quality Lead and QP, you will ensure that batches have been manufactured and checked in accordance with the requirements of the Marketing Authorisation (MA) and within Good Manufacturing Practice, cGMP.
4.As the Quality Lead you will manage the Quality agreements with contract givers and third-party providers as well as managing the archiving of all GMP documentation.
To be successful in your application to this exciting opportunity as the Quality Lead QP we are looking to identify the following on your profile and past history:
1. Graduate (or equivalent) qualification in a scientific discipline who is an eligible QP (i.e can be appointed towards a manufacturers license) with proven experience of effectively leading and managing technical professional teams in a highly regulated GMP environment.
2. Demonstrated evidence of providing effective business solutions and plans with demonstrated use of Operational Excellence to deliver sustained improvement and it is expected you will have a proven track record of Project Management and good planning skills.
3. To be successful as the Quality Lead, QP it would be expected that you have experience in successfully handling regulatory interfaces such as inspections and fronting audits with a detailed knowledge to both GMP and the application of the principle of Quality Management System (QMS).
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.