QC Team Leader- Contamination Control

1 week ago

Stirling Scotland, Scotland, United Kingdom SRG Full time

SRG are working with a dynamic life science organisation who are going through a period of continued growth and currently looking for a QC Team Leader within Contamination Control to join the team.


This is the perfect opportunity for someone with a strong skillset in contamination control to lead the team and drive processes and improvements going forward.


The successful applicant will receive a generous salary and benefits including annual bonus scheme. There is also scope for some hybrid working after completion of probation.


The Role:

  • Support leading the organisation and Quality Control team in maintaining comprehensive quality control systems to maintain inspection readiness for Manufacturing Authorisations.
  • Responsible for ensuring adherence to quality control systems to ensure that products manufactured are of set quality required for Investigational Medicinal Product and Licensed Medicinal Product Use.
  • Support the Head of QC in leading the day to day management of the operational performance of the Quality team focusing on Quality Control.
  • Line management of the contamination control team members.
  • Act as a subject matter expert (SME) on all contamination control activity and processes. Develop, monitor, improve and maintain procedures to ensure compliance with Good Manufacturing Practice (EU/FDA and other appropriate standards) for the manufacture and testing of pharmaceuticals.
  • Ensure all testing is carried out as per the approved technical agreement and results are approved against the appropriate specification.
  • Develop and maintain specifications, sampling procedures, testing methods (including validation and transfers).
  • Ensure batch certification duties in accordance with relevant procedures and provide support to the Qualified Person for GMP Compliance and Certification.
  • Collaborate with an organization’s technical and supply chain departments manager to ensure materials from external suppliers meet quality requirements as defined by EU/FDA/EP/USP or other appropriate standards.
  • Develop, implement and monitor Continuous Improvement activities.
  • Provide QC coaching/guidance for cross functional groups to ensure compliance.
  • Provide training to other team members
  • Lead investigations and report quality issues including non-conformances (NCR), out of specifications (OOS), out of trends (OOT) and environmental monitoring excursion (EME) investigations, escalating to management as required.
  • Responsible for environmental monitoring awareness including knowledge transfer and training for the manufacturing team.
  • Lead site EM trending to report and also for any client audits / regulatory inspections.


Requirements:

  • Educated to degree level in a relevant scientific discipline or equivalent experience.
  • Strong background and understanding of Microbiology and related processes within a pharmaceutical environment.
  • Extensive experience working in a cGMP environment and strong understanding of regulatory requirements.
  • Prior experience and knowledge of working in cleanrooms and the requirements of maintaining a sterile environment.
  • Experience of aseptic technique and able to impart this knowledge to other team members.
  • Good understanding of pharmacopoeia requirements in relation to contamination control.
  • Able to lead a small team and drive completion of work.
  • Adaptable and able to prioritise in a fast-paced environment.
  • Comfortable driving process change across teams and being able to articulate reasoning and importance of certain processes.
  • Must be a “self-starter” and doesn’t require constant instruction.


Please note, applications from Senior QC Officers displaying strong skills in the above will also be considered.

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