Sterility Assurance Manager - Seneffe, België - Thermo Fisher Scientific

Thermo Fisher Scientific

Geverifieerd bedrijf

Seneffe, België

3 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Mission of function

Production of biopharmaceutical products conform to the requirement of international quality defined by the FDA, the EMEA, the ICH, etc.

The sterility Assurance Lead (SAL) role is charged with encouraging 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 embracing and harmonizing best aseptic practice (20%).

Context of position and function

This type of facility needs to be conformed to the rules et regulation of the BPF established by the ministers of health and the social protection of countries, as well as the international directives.
The production activities need to be driven in an effective and efficient way to guarantee the global competitiveness of the sites. Besides, due to the very high value of the intermediate products and products, the production activities need to be driven in a highly controlled way.
The control of the production activities and the rules, regulation and cGMP directives compliance are needed for the client's products adequation and the site operating license. The principal contacts are within its own department.
Content of the function

A) Principal areas of 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 onsite to assess compliance, identify improvements and provide realtime mentoring to aseptic staff
Define, coordinate and where necessary improve the EM & APS programs.
Ensure that all sterilization processes are being handled 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 sites
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 timely reporting and investigation of all accidents, near misses, and breaches of rules.

B) Contact with the authorities

Support and active participation to the audits and inspections

Complexity of the function

Ability to work in a fastpaced, matrix environment essential
Capable of working to deadlines and prioritize multiple tasks
Strong leadership skills with good teamwork, communication and problemsolving skills.

Knowledge and level of education

Minimum Sciencebased degree in Microbiology
Meaningful experience, between 510 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.
Is not afraid to make decisions. Holds self and others accountable in achieving goals.
Excellent written and verbal communication skills to internal and external stakeholders
Wants to learn and have a natural curiosity to understand systems and processes
Flexibility to meet changing needs and priorities of the business
Experience of developing and influencing business strategy is desirable