Back to previous page

QC Team Leader- Contamination Control

Job Type
Permanent
Location
Stirling
Salary
Competitive package
Job Ref
BBBH145269_1717493531
Date Added
June 4th, 2024

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 skill-set 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 organisation'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.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

Apply to this Job


Share this Job

More Information

Subscribe to our newsletter

Stay up to date with SRG