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  • WEST YORKSHIRE - PART TIME

GMP QA DOC CONTROLLER

Closing date for applications: 6 February 2023


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 are looking for a hard working individual who is capable of working independently and as a part of the GMP QC team. To begin with, this role will be part-time (20 hours) with the possibility of increasing to full time following a review after 6 months and will be based at our Leeds site.


You will need to have the ability to prioritise workload and deal with changes to priorities to support a fast-paced ever changing manufacturing environment. A high level of Microsoft skills to facilitate and support the quick release of documentation is crucial.


Main responsibilities, to include issuing, maintaining, and management of highly regulated documents for a fast past clinical manufacturing department.


FOCUS OF THE JOB:

  • Management of GMP and IMP SOPs and Forms according to regulatory requirements

  • Release and issue of GMP and IMP 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

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

  • To assist with the reconciliation of the issued documentation

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

  • Good interpersonal skills

  • Very good skills with Microsoft Office (eg Word, Excel)

  • Ability to manage and maintain spreadsheets, and proficient in other common Microsoft applications.

  • Good attention to detail and excellent organisational ability

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

  • Document Controller experience would be an advantage

  • Some experience working in a regulated industry 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.


Job Description - GMP QA Doc Controller
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Salary: Competitive + Negotiable £ Apply Now

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