Technical Leader Analytical Cleaning Verification - Loughborough, United Kingdom - Marketplace BDMS Limited

Marketplace BDMS Limited
Marketplace BDMS Limited
Verified Company
Loughborough, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Leading Analytical Development company seeks an experienced Technical Leader (Analytical Cleaning Verification)


About the role:

To provide technical leadership and coaching for cleaning analysts and technicians.


The post holder will be responsible for carrying out and monitoring the development and validation of analytical testing methods for cleaning verification/validation, the testing and release of operational equipment and the completion of any associated documentation.


Duties may include:


  • Provide technical and operational leadership, training and coaching to Senior Cleaning Analysts, Cleaning Analysts and Technicians.
  • Take full ownership for the analytical activities required for cleaning verification/validation. Identifying technical problems/issues, developing solutions and fully implementing these solutions with agreement from their line manager/departmental managerwhere appropriate.
  • Define the analytical strategy for new and ongoing projects as related to cleaning verification/validation.
  • Maintain and demonstrate a good working knowledge of pharmaceutical cleaning verification/validation strategies and appropriate method development techniques.
  • Actively manage the performance of Senior Cleaning Analysts, Cleaning Analysts and Technicians assigned as their direct and indirect reports.
  • Ensure laboratory cGMP procedures/systems are adhered to and investigate/manage any noncompliance issues (where appropriate involving their Team or Group Leader).
  • Take full responsibility for quality investigations and ensure all investigations are conducted in a thorough and timely manner in accordance with procedures.
  • Provide support as required during Client/regulatory cGMP audits and complete all assigned actions from audits promptly.

Skills and experience:


  • Previous experience within a pharmaceutical GMP environment.
  • Cleaning validation.
  • Rinse sampling for cleaning verification.
  • Statistical data analysis techniques.
  • Supporting facility improvements writing protocols and reports.
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