GMP Production Manager

2 weeks ago

United Kingdom MAC Clinical Research Full time

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 dedicated GMP/Pharmacy Production team in Manchester.

FOCUS OF THE JOB:

  • Named as a “Supervisor of Production” on the MHRA MIA (IMP) licence.
  • Line Manager of Production Staff at the Manchester Site.
  • To work harmoniously with the Pharmaceutical Services Manager, QPs, Quality and Clinical Trials Pharmacists.
  • To assist in the leading, delivery and evaluation of production services including aseptic services.
  • Oversee training of production staff at the Manchester site.
  • To liaise with staff including the Medical Director, PI (Principal Investigator), Sub- Investigators, Site Directors, Feasibility/Proposals, 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.
  • To act as primary contact for designated trials and Pharmaceutical Services Manager as required.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

  • Good, current knowledge of UK & EU Good Manufacturing Practice
  • Good, current knowledge of Good Clinical Practice
  • Experience with clinical trials
  • 5 years within a leadership or managerial role (desirable)
  • Senior Technician experience (desirable)
  • Systems experience with organising, planning, delegating and reviewing
  • 1 year (minimum) in validation

RESPONSIBILITIES:

  • Ensure compliance of the 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.
  • Assist in 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.
  • Assist in checking the maintenance of the department, premises and equipment.
  • Ensuring that the appropriate equipment and process validations are carried out to GMP standards.
  • Assist in the required initial and continuing training of department personnel.
  • Assist in the authorisation of written procedures and other documents, including amendments.
  • Ensure the monitoring and control of the manufacturing environment.
  • Ensure plant hygiene standards are maintained.
  • Assist in the approval and monitoring of suppliers of materials.
  • Assist in 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.
  • Assist in the monitoring of compliance with the requirements of Good Manufacturing Practice.
  • Assist in the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
  • Active 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.

BENEFITS:

  • Competitive salary in keeping with pharmaceutical industry standards and 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.

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