Sterility Assurance Lead

Job content

Position Summary

The sterility Assurance (SA) lead role is charged with championing good SA practices across site. This role is to be the single person leading sterility assurance within the aligned business unit and will own/promote/define the systems listed as key responsibilities (80%). The role is also an integral part of a matrix SA organization both within the site and across the different sterile sites within the network as is charged with adopting and harmonizing best aseptic practice (20%).

Responsibilities

For the aligned business unit (not less than 80% of role):

• 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.
• Conduct 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 where necessary 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 and must 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 ensure that SA practices stay aligned with current and future regulatory expectations.
• Lead major investigations into issues 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 practices and actively share that knowledge.
• 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)
  

Eh&s

• Understand and ensure implementation of emergency procedures and safe systems of work
• Ensure compliance with environment, health, and safety rules, signage, and instructions at all times
• Ensure prompt reporting and investigation of all accidents, near misses, and breaches of rules.
  

Minimum Requirements/Qualifications

• Minimum Science-based degree in Microbiology
• Substantial experience, minimum 5 years working in or directly supporting manufacturing within a sterile pharmaceutical manufacturing site. This position requires a deep understanding of sterile product manufacture and good aseptic practices. This knowledge needs to be combined with quality risk management principles.
• Strong working knowledge of the principles and guidelines for GMP as set out in the Eudralex Volume 4, U.S. 21CFR part 210/211 and able to operate as a subject matter expert on regulations pertaining to aseptic manufacturing such as EU Annex 1 and the FDA aseptic processing guide.
• Is not afraid to make decisions. Holds self and others accountable in achieving goals.
• 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
  

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Job Summary

Job number: 162771BR

Date posted : 2021-05-28

Profession: Quality & Regulatory

Employment type: Full-Time