MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We have an exciting opportunity for a Production Manager to join our busy GMP Team in Leeds, West Yorkshire.
Hiring managers are looking for candidates who have GMP, GCP, validation and a-septic experience. You’ll also need to have at least 5 years’ 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.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
- Good knowledge of Good Manufacturing Practice
- Good knowledge of Good Clinical Practice
- Experience in validation
- Familiar in working in a-septic environment
- 5 years previous experience in leadership role
- Clinical trials experience
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, in order 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 work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
- To work according to MAC SOPs, guidelines and policies
- To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business related data.
- To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out
- 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.
BENEFITS:
- Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
- Health Insurance
- Free onsite parking
- 25 days annual leave (increasing in increments to 30 days after 6 years' service)
- Your birthday off work
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.
Please email maccareers@macplc.com 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.