QA Gmp Specialist - Genappe, België - Keyrus Life Science Belgium

Keyrus Life Science Belgium
Keyrus Life Science Belgium
Geverifieerd bedrijf
Genappe, België

2 weken geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

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Beschrijving

What we offer
Joining our consulting team in Belgium means giving your career a step forward.

Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.


As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager.

We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.


We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth.

On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization ) based on your background and experience.


Keyrus Life Science is looking for a
Quality Assurance Good Manufacturing Practices
(QA GMP) Specialist
to join our consulting team for a client project based in Walloon Brabant**.

This position will support operational Quality Assurance activities for our client's biological development projects.

This will be achieved through close partnering with QA at our client and vendor sites, and collaboration with the client's Technical Operations and other teams.


Your challenges will be to work closely with
Technical Operations teams to ensure that all QA services for the project are provided in an effective and efficient way.

Provide
advice and support on
operational and general QA activities to teams working on Drug Substance (DS) and Drug Product (DP) development, Technology transfer, manufacture and submission preparation.


In particular:
-
Manufacturing and Disposition Support:review and approval of manufacturing and disposition documentation, for example:

  • Process description, Manufacturing description and master batch records
  • Analytical methods
  • Specifications
  • Completed Internal & CMO batch documentation
  • Deviations, Change controls, CAPA
  • Release of raw materials & consumable
-
Gemba and Spot Checking:


  • Plan and manage shop floor spotchecks of the GMP area, offering quality assurance support including, but not limited to inspection.
  • Verification of results reported in reports with raw data

Reviews will include:

  • Check of referenced documents and data
  • Compliance with relevant protocol, SOP or GMP guideline
  • Compliance with regulatory guidelines
  • Deviations and changes are properly addressed and documented
  • Consistency with other documents
  • Discussions and conclusions are pertinent and consistent with data
  • Comments from review are correctly addressed

Other Activities:


  • Assist with induction of new team members
  • Provide support to other project related activities

Profile

  • Bachelor's degree.
  • 5 years of relevant experience in industry:
  • Pharma;
  • Quality assurance;
- and GMP (good manufacturing practices).

  • In case of experience with biologics: only 3 years needed
  • Need experience with at least one of the following:
  • Regulatory submission preparation for biological products
  • ICH Q2 analytical method validation principles and general analytical techniques
  • GMP process validation
  • DS and/or DP process manufacture for biological products
  • Good knowledge & Understanding in GMP Guidances, compliance principles and theories including risk management (Eudralex, CRF's, ICH )

Who we are


Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.

Our 'human' approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.


At Keyrus Life Science we're proud of our commitment to delivering services of the highest quality, not only skilfully, efficiently and reliably, but also with sincerity and genuine care for our clients' projects, priorities and reputation.

Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

From early
- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
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