GMP Production Manager

We have an exciting opportunity for a Production Manager to join our busy GMP Team in Leeds, West Yorkshire.  

Our Hiring Managers are looking for candidates who have a strong knowledge of GMP, the ability to plan and execute complex projects and experience of working with graded manufacturing suites. You’ll also need to have experience in a leadership role.   

FOCUS OF THE JOB: 

• Named as the “Production Manager” on the MHRA MIA (IMP) licence. 
• To be responsible for the leading, delivery and evaluation of comprehensive production services including aseptic services. 
• Responsible for training of production staff. 
• To liaise with staff including the Medical Director, PI (Principal Investigator), Sub- Investigators, Site Directors, Project Managers and CTAs, regarding requirements for studies of Investigational Medicinal Product (IMP) / commercial and comparator 
• To liaise with sponsors, vendors and customers for pharmacy production queries and guidance. 

MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.

• Strong knowledge of Good Manufacturing Practice 
• Experience in validation 
• Familiar in working in Graded Manufacturing Suites 
• Previous experience in a leadership role 
• Clinical trials manufacturing experience would be beneficial but not expected. 
• Great organisational skills and the ability to manage projects. 
• Knowledge and experience with Quality Management Systems

RESPONSIBILITIES:

• Ensure compliance of Manufacturing Unit with EU GMP 
• Ensure that products are produced and stored according to the appropriate documentation so that they reach the appropriate standards of quality 
• Approving the instructions relating to production operations and ensure their strict implementation 
• Ensuring that the production records are evaluated and signed by an authorised person before they are sent to Quality Control (QC) Department 
• Checking the maintenance of their department, premises and equipment 
• Ensuring that the appropriate equipment and process validations are carried out to GMP standards 
• Ensuring that the required initial and continuing training of their department personnel is carried out and adapted according to need 
• Authorisation of written procedures and other documents, including amendments 
• The monitoring and control of the manufacturing environment, 
• Ensure plant hygiene standards are maintained 
• The approval and monitoring of suppliers of materials 
• The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activates 
• The designation and monitoring of storage condition of materials and products 
• Responsible for paper documentation and electronic record retention 
• The monitoring of compliance with the requirements of good manufacturing practice 
• The inspection, investigation, and taking of samples, to monitor factors which may affect product quality 
• Participation in management reviews of processes performance, product quality and of the quality management system and advocating continual improvement 
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management 
• Compliance with MAC health and Safety policy 
• Compliance with MAC policy on equality and diversity 
• To maintain professional qualifications required for the role, including continuous personal development 
• To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers 

PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS: 

• Required to travel to individual MAC Research sites as appropriate for training, equipment issues and client visits. 
• Required to work in aseptic environment. 

• Health Insurance
• Free onsite parking
• 25 days annual leave (increasing in increments to 30 days after 6 years' service)
• Your birthday off work

Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.