30+ days ago
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
At our site in Swindon, Thermo Fisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs.
The sterility Assurance (SA) lead role is charged with championing SA principles across site. This specific role is to be the single person accountable for sterility assurance within the aligned business unit and will own/promote/define the systems listed as key responsibilities (80%). The role is an integral part of a matrix SA organization both within the site and across the different sterile sites as is charged with adopting and harmonizing aseptic practices at all sites within the network (20%).
What will you do?
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 and 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. It should be appropriate to the SA related tasks each person conducts.
Ensure that all sterilization processes are being managed compliantly
Conduct risk assessments and improvement programs to maintain SA practices stay aligned with current and future regulatory expectations.
Lead major investigations into issue impacting SA (i.e. Adverse EM trends, media fill failures)
Review & approve any major/critical deviation and any change proposals with SA impact.
Stay up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
Implementing best practice (e.g. ensuring understanding / compliance with SA related regulations & guidance – owning the transition and any risk assessments we need.
Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)
Act as the backup for SA lead(s) assigned to other business units on site
In addition (up to 20% of role)
Actively represent the site/business unit within the SA Working Group actively harmonizing practices across sites in the network.
Participate in SA audits at other sites in the network (as required)
Act as the lead for the group (potential future development opportunity for all SA leads)
Who are we looking for?
Minimum Science based degree in Chemistry, Pharmacy or Microbiology
Substantial experience working in a pharmaceutical Quality department on a sterile site. This position requires deep understanding and proven application of cGMP regulations and international guidelines in a sterile production setting. This knowledge needs to be combined with clear decision making, pragmatism aligned with quality risk management principles to demonstrate release of product appropriate for commercial use.
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 oversight
Eligible to act as a ‘Qualified Person’ as defined in 2001/83/EC and 2001/82/EC (as amended), is preferable but not essential
Strong 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
Is not afraid to make decisions for the group. Holds self and others accountable in achieving goals
A proven track record of developing and leading a high-performance team
Strong leadership skills with good collaboration, communication and problem-solving skills
Excellent written and verbal communication skills to internal and external stakeholders
Wants to learn and have a natural curiosity to understand systems and processes
Ability to work in a fast paced, matrix environment essential
Capable of working to deadlines and prioritize multiple tasks
Flexibility to meet changing needs and priorities of the business
Experience of developing and influencing business strategy is desirable
What’s in it for you:
Competitive base salary
Free on-site car parking
Private medical insurance
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Apply today! http://jobs.thermofisher.com