Sterility Assurance Lead

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

Sterility Assurance Lead – Swindon, UK – Initial 6-Month Contract – Life Sciences

Would you like to support one of the largest CMO’s in the world? Well look no further as we may have the opportunity for you! Our client is seeking a Sterility Assurance Lead to support their project located in Swindon for an initial 6 month duration. It is a fast paced and exciting environment which is seeing a lot of internal investment. This is the chance to get involved with a global client who is going from strength to strength. With several exciting refurbishment projects in the pipeline this is a great chance to be involved in the full project lifecycle with the opportunity to move into other projects and areas of the business.

What you’ll deliver:

• Generate and maintain the contamination control strategy
• Promote understanding of and compliance to SA related regulations such as EU Annex 1 & the FDA’s aseptic processing guide.
• Implement regular GEMBA style assessments of the aseptic process on site to assess compliance, identify improvements fand provide real time coaching to aseptic staff
• Define, oversee and improve the EM & APS programs.
• Ensure that suitable aseptic comportment/training/oversight programs are in place and effective. The programs should cover aseptic operators and the first line managers/quality staff charged with overseeing aseptic manufacturing.

Experience required:

• Minimum Science based degree in Chemistry, Pharmacy or MicrobiologySubstantial experience working in a pharmaceutical Quality department on a sterile site.
• Substantial Quality Assurance experience and ‘hands‑on’ knowledge of all Quality Systems required for a sterile manufacturing facility.
• Understanding of the principles of sterile manufacturing.
• Demonstrated ability to make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA oversightStrong working knowledge of the principles and guidelines for GMP as set out in the Orange Guide, Eudralex Volume 4, U.S. 21CFR part 210/211 and other relevant regulations