Sterility Assurance Lead – Aseptic Excellence & GMP Leader

QCS Staffing Ltd; Swindon; On-site; GBP 60,000 - 70,000; Full time

Job summary

QCS Staffing Ltd is seeking a Sterility Assurance Lead for a Swindon site on a six-month contract with a global CMO client. The role centers on developing and maintaining the contamination control strategy and ensuring regulatory compliance in a fast-paced life sciences environment.

You will oversee QA oversight, define and improve EM & APS programs, deliver aseptic training, and coach aseptic staff and managers.

Qualifications

• GMP knowledge and quality systems experience in sterile manufacturing.
• Hands-on QA experience in sterile site environments.
• Understanding of regulatory expectations for GMP and sterile production.
• Experience evaluating GMP compliance and leading QA oversight.

Responsibilities

• Generate and maintain the contamination control strategy.
• Promote compliance with EU Annex 1 and FDA aseptic processing guidance.
• Perform GEMBA-style assessments of aseptic processes on site and coach staff.
• Define, oversee and improve EM and APS programs.
• Ensure aseptic comportment, training and oversight for operators and frontline managers.

Skills

GMP knowledge

Sterile manufacturing

Quality systems

Regulatory knowledge

Education

Science-based degree (Chemistry / Pharmacy / Microbiology)

Job description

QCS Staffing Ltd is seeking a Sterility Assurance Lead for a Swindon site on a six-month contract with a global CMO client. The role centers on developing and maintaining the contamination control strategy and ensuring regulatory compliance in a fast-paced life sciences environment.

You will oversee QA oversight, define and improve EM & APS programs, deliver aseptic training, and coach aseptic staff and managers.