Closing date for applications: 4 January 2021
MAC Clinical Research manages clinical trials for the pharmaceutical industry and an exciting range of career opportunities exists in our expanding Clinical Development Organisation.
We are seeking to appoint an experienced Production Manager to join our dedicated Pharmacy Team in Leeds.
The successful candidate will be named as the “Production Manager” on the MHRA MIA (IMP) licence, responsible for training of production staff and the focus of the role is to be responsible for the leading, delivery and evaluation of comprehensive production services including aseptic services.
Excellent communication skills and the ability to work within a team are essential.
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
Liaise with sponsors, vendors and customers for pharmacy production queries and guidance
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
Approve the instructions relating to production operations and ensure their strict implementation
Ensure that the production records are evaluated and signed by an authorised person before they are sent to Quality Control (QC) Department
Check the maintenance of their department, premises and equipment
Ensure that the appropriate equipment and process validations are carried out to GMP standards
Ensure that the required initial and continuing training of their department personnel is carried out and adapted according to need
Authorise written procedures and other documents, including amendments
Monitor and control of the manufacturing environment
Ensure plant hygiene standards are maintained
Approve and monitor suppliers of materials
Approve and monitor contract manufacturers and providers of other GMP related outsourced activates
Designation and monitor storage condition of materials and products
Paper documentation and electronic record retention
Monitor compliance with the requirements of good manufacturing practice
Inspect, investigate, and take 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
Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
Good knowledge of Good Manufacturing Practice
Good knowledge of Good Clinical Practice
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave (increasing in increments to 30 days after 6 years long 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 note that if we receive a high volume of applications this date may be brought forwards.
Salary: Competitive + Negotiable £ Apply Now