Sr Manager, QA Operations - Seneffe, België - Thermo Fisher Scientific

Thermo Fisher Scientific

Geverifieerd bedrijf

Seneffe, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Take part to the business entity's growth by ensuring high value products disposition in a controlled manner Be the owner of processes compliance by following daily routine of the manufacturing steps and associated services while partnering and interacting with qualified person and other relevant key positions in all departments.

Content of the function
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Team
Coach, lead and contribute to the success of you team

Define resources to be able to execute the daily routine in a timely-manner.

Optimize resources to focus on efficience of the team and their goals.

Be responsible for the training and the understanding on theoretical and practical procedures

Operational

Review the documentation linked to manufacturing areas

Help to define quality requirements related to projects

Manage and approve all types of quality events linked to their scope

Bring quality expertise for contracts discussions

Be the contact for client and project manager (from master cell/viral banks to filling step)

Coordinate and approve products' documentation (specification sheet, procedures, master batch record, executed batch record,...)

Support and active participation to the audits and inspections
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Operational Excellence
Own the culture of efficiency and quality in their team and contribute to influence all others departments

Made proposals for improvements for manufacturing and/or organisation. Lead by example to have a change mindset with their team.

Made regular on-site visit

Create adequate performance indicators and have a follow up

Skills

Wellversed on EU and US cGMP requirements for clinical and commercial biologics cell/gene therapy manufacturing is an asset
Capable to understand operational document with the view of compliance, accuracy and exhaustivity requested by GMP
Customercentric attitude with business sense
Ability to advise on regulatory solutions and influence partners
Soft and hard skills well developed
Good in communication, written and orally, internal/external
Fluent in French and English

Knowledge and level of education