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Quality Manager

Remote, Orkney Isles   •  Permanent, Full time

CK Group are recruiting for a Quality Manager to lead all quality activities related to GMP secondary packaging and labelling, on behalf of a global clinical trial supply and solutions provider. This role is offered on a permanent basis, and is available for fully remote working, or could be site based from Leicestershire.

About the Company:
Our client is a well established leader in their field, offering complete solutions to ensure that their partners execute successful clinical trials. They have a global client base, dealing with around 2000 clinical trials annually, from their facilities around the globe.

About the Role:
The main purpose of this varied role is to lead on some exciting projects as they continue to grow their team and business. You will ensure all GMP labelling activity is completed in line with EU GMP and MHRA requirements and internal procedures, including collaborating with department heads to schedule GMP labelling process tasks to meet client requirements. This role is responsible for GMP Quality Control activities.

Your responsibilities will include:

  • Leading a small team with a hands-on people management approach, to encourage development and drive efficiency.
  • Ensuring that all GMP activity is completed as defined in SOPs including approving or rejecting imported IMPs, starting materials, packaging materials, and intermediate, bulk and finished products and evaluating batch records.
  • Approving GMP activity and releasing labelled Non-IMP as well as acting as the main contact with the Qualified Person relating to day-to-day GMP labelling activity and releases.
  • Ensuring that deviations and complaints relating to GMP labelling are appropriately raised and investigated with determination of most likely root cause(s), and liaising with related departments/Qualified Person as required, approving deviations and establishing appropriate CAPA.
  • Authoring, review, approval and close of GMP related change controls and complaints as per procedural requirements.
  • Performing on-site audits of suppliers/subcontractor relating to GMP labelling and host customer audits as required.
  • Authoring, review and approval of Standard Operating Procedures and other controlled documents relating to GMP labelling activity.

About you:
To be considered for this position, you should ideally have the following skills and expertise:

  • Educated to degree level or above in life sciences or a related with significant experience of Quality Assurance in a GMP pharmaceutical environment, particularly in regards to clinical trial labelling.
  • Good knowledge of current EU GMP/GDP regulations and particularly around labelling and packaging.
  • Excellent written and verbal communication skills as well as organisation and project management skills.
  • Previous line management experience isn't essential but it is important to have the ability and interest to lead a team and develop staff.

The benefits:
Our client offers an exceptional range of employee benefits, including;

  • Extremely competitive salary
  • Performance-related bonus (up to 15% of your salary)
  • 29 days? holiday plus bank holidays
  • Contributory pension scheme
  • Private medical insurance (after qualifying period)
  • Progression and development opportunities

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54457 in all correspondence.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 54457
  • Posted: 23rd September 2022
  • Expires: 21st October 2022

CK Group

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