PRODUCTION MANAGER
Closing date for applications: 18 October 2024
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.
Salary: Competitive + Negotiable £ Apply Now