GMP QA DOCUMENT CONTROLLER AND TRAINING COORDINATOR

Closing date for applications: 13 September 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’ve an exciting opportunity for a hard-working individual who can work independently and within a team. This role will be office-based at our site in Leeds, West Yorkshire, within our manufacturing department, working 30 hours per week. There may be instances where some travel to Manchester site will be required.

You will be supporting the manufacturing site in aspects of issuing, releasing and maintaining manufacturing/GMP (Good Manufacturing Practice) related paper documents. The ideal candidate will also be responsible for organising, booking and maintaining a comprehensive record of the team's training and training status.

FOCUS OF THE JOB:

• Management of GMP SOPs and Forms according to regulatory requirements

• Release and issue of GMP SOPs and Forms as per the appropriate procedures

• Release and issue of GMP Unit Production Specific Documentation such as validation plans, reports, material specifications, and technical documents.

• Release of GMP Study Documentation

• Generation and organisation of Induction training, ensuring timely completion

• Organisation and follow up of Trainer Led Training, Dry Run and Competency Training

• Organisation and follow up of annual training, ensuring all annual training presentations are correct and up to date

• Ensuring trainers are approved and training is up to date include all annual reviews, prior to training runs with trainees

• Monitoring of training plan execution, and paperwork review

• Maintenance of the training log

• To assist with the preparation of essential documents required for batch manufacturing and release activities

• To assist with the reconciliation of the issued documentation

Main Responsibilities

• Issuing, release and maintenance of the GMP Unit SOPs with applicable regulations.

• Management of the GMP Unit SOPs, Forms and Template

• Issuing release and maintenance of GMP Unit specific documentation

• Assisting with the hosting of external audits or inspections from clients or regulators.

• Assisting in facilitating quality improvements

• Issue and Reconciliation of production forms for use

• Set up GMP training files and organise site induction training for new starters

• Maintenance of the GMP Training programs, including reminders and follow up

• Maintenance of the GMP training log and trainer status

Key Skills and Requirements

• Experience in and admin role in a similar industry (GMP manufacturing, food manufacturing) (essential)

• Experience with processing and storing GMP documentation

• Good interpersonal skills

• Very good skills with Microsoft Office (e.g. Word, Excel)

• Good attention to detail

• Good communication and excellent organisational skills

• Sufficient initiative to be able to work alone and with a team

• Some experience in a clinical environment would be useful

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.

Job Description - GMP QA Document Controller and Training Coordinator

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