Compliance Coordinator

4 weeks ago

Loughborough, United Kingdom Kindeva Drug Delivery Full time

Kindeva Drug Delivery is on a mission to solve drug delivery challenges and change patients’ lives worldwide, and we are able to achieve this due to our innovative, collaborative team. If you want to grow your CDMO career and be a force for good, you will have everything you need to excel at Kindeva.

With over a century of experience in combination product development and manufacturing, Kindeva is truly a global force in drug delivery. We have state of the art facilities across the US and UK and our capabilities span delivery formats, from ideation through commercialisation.

At Kindeva, we manufacture more tomorrows. Our products change and save lives across the world, and we are committed to developing meaningful and powerful solutions for our partners and the patients we serve. Every member of our team contributes to this mission, making a real difference, every day.

Position Summary

We are looking for a Compliance Coordinator to join the Inhalation Drug Delivery Compliance Group. The role involves providing general administrative support to the compliance team and specifically supporting the calibration co-ordinator to ensure that the area remains compliant with ISO 9001 and Current Good Manufacturing Practice (cGMP)

The successful candidate will be responsible for:

  • Working safely and in line with the highest standards of Current Good Manufacturing Practice (cGMP).
  • Managing updates to Calibration Assessment Forms (CAFs) ensuring they are completed in line with the Standard Operating Procedure (SOP).
  • Managing archiving of generated historical calibration files.
  • Completing Planned Maintenance Requests (PMR) as and when required to ensure alignment with the ERP system (D365) and actual calibration dates.
  • Uploading completed calibration certification onto D365 as part of monthly asset closures.
  • Updating departmental documentation that covers a wide range of processes and procedures within the Quality Management System (QMS) .
  • Identifying and implementing improvement ideas.
  • Training as secondary contact to the Calibration Coordinator.

Key Attributes:

  • GCSE (or equivalent) Grade C (or above) in English and Maths
  • Proficient with Microsoft Office applications
  • D365 and MasterControl knowledge preferable but not essential
  • Able to work independently or as part of a team
  • Excellent organisational skills, ability to multitask and an eye for detail
  • Good communication and interpersonal skills
  • Able to work to deadlines
  • Reliable

What we will give to you:

  • Attractive compensation package
  • Company pension scheme (up to 10% employer contribution)
    25 days holiday per year (plus bank holidays) plus service days after 5 years
  • Company sick pay
  • Employee Assistance Program with 24/7 confidential helpline support for employee and immediate family
    Life assurance of four times life cover salary
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