Corporate Microbiologist Associate - Braine-l'Alleud, België - UCB

UCB
UCB
Geverifieerd bedrijf
Braine-l'Alleud, België

1 week geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

Make your mark for patients
We are looking for a motivated
Corporate Microbiologist Associate to join us in our
Sites Quality Operations team.


About the role
The primary purpose of the Corporate Microbiologist Associate is to be the point of contact for microbiology & virology to provide expertise, guidance, strategy for:

  • Pharmaceutical and Biopharmaceutical commercial manufacturing, including quality and product lifecycle.
  • Pharmaceutical and Biopharmaceutical development.
  • Regulatory affairs, for the submission of new drugs to authorities' approval.
In this role, you will also follow-up, evaluate, and cascade the impact of new regulations and evolving industry practices:

  • By endorsing SME role for Regulatory intelligence.
  • By representing UCB in industry organizations.
  • By authoring position papers in microbiology / virology topics impacting the global organization.
  • By acting as a corporate process owner, in global processes related to microbiology / virology.

Who will you work with


You will work with a team of microbiologist, part of the transversal Sites Quality Operations department in the corresponding area of Manufacturing, Engineering & HSE.

You will partner with UCB site's manufacturing & development, Quality Assurance, Regulatory Affairs, as well as with UCB external network.


What will you do

_ Compliance:
_

  • Review and assess the impact on a global scale of GMP/GLP & Pharmacopoeia changes for microbiology & virology related chapters.
  • Give recommendations and if necessary, participate in implementations of regulatory changes microbiology / virology topics on a local scale. When appropriate, write position papers in microbiology / virology topics impacting the global organization.
  • Ensure that corporate standards are up to date, by acting as a corporate process owner, in global processes related to microbiology / virology & reviewing standards related to sterility assurance and bioburdencontrolled processes.
  • Act as the RIN expert for microbiology/virology topics.
**_

Quality:
_**- Give recommendations and if necessary, participate in:
  • The investigations related to major microbiology & virology issues across the organization.
  • The review to ensure that protocols / reports for microbiology & virology methods suitability test issued by CMO / CLO and internal manufacturing quality operations are compliant with regulations, with internal standards, policies, and procedures.
  • The review of major deviations & out of specifications for microbiology & virology issued by CMO / CLO and internal manufacturing quality operations to ensure that they are addressed in compliance with regulations, internal standards, policies, and procedures.
  • The review of change control to ensure that major change control related to microbiology & virology issued by CMO / CLO and internal manufacturing quality operations are addressed in compliance with regulations internal standards, policies, and procedures.
  • Provide guidance and expertise in the definition / implementation / lifecycle of microbial & viral control strategies for manufacturing.
**_

Regulatory:

_**- Give recommendations and if necessary, participate in review / approval of the submission file to ensure that cell bank & virology methods described are compliant with regulations and aligned with internal standard, policies, and procedures.


Interested? For this role we're looking for the following education, experience and skills

  • Master's Degree
  • Minimum 10 years of experience in pharmaceutical environment.
  • Strong experience in pharmaceutical manufacturing environments & constrains, including quality assurance & control.
  • Good knowledge in compendial microbiology & virology methods & GMPs in pharmaceutical industry.
  • Good knowledge in operational excellence.
  • Fluent in English & French.
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you


About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.


Why work for us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients.

We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.

We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees or our planet.

Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.


Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we
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