Process Validation Expert - Annex 1 (m/f/d).

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job details

summary.

  • specialism
    administration
  • contact
    Laurène Soumahin
  • reference number
    129085-40097

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job details

The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.

To evolve in this environment, we are looking for our next Process Validation Expert to ensure the coordination of production troubleshooting and Annex 1 project related.

You will be responsible for:

  • Contribute to strategy elaboration for Annex 1 remediation in collaboration Process Insight Associate Manager and other departments
  • Establish relevant change control proposals related to the projects with Process Insight Associate Manager and integration of the projects in the Site Project Manager roadmap for each products when applicable.
  • To ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP), Discoverant…
  • Assure the timely delivery of required documents (plans, protocols and reports…) as defined in the project plan
  • Ensure that all process support activities are carried out at appropriate compliance levels
  • Participate to the establishment of raw material control strategy in relation with suppliers and the MSAT Raw material specialist

The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within our client site in Aubonne to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements.

To evolve in this environment, we are looking for our next Process Validation Expert to ensure the coordination of production troubleshooting and Annex 1 project related.

You will be responsible for:

  • Contribute to strategy elaboration for Annex 1 remediation in collaboration Process Insight Associate Manager and other departments
  • Establish relevant change control proposals related to the projects with Process Insight Associate Manager and integration of the projects in the Site Project Manager roadmap for each products when applicable.
  • To ensure appropriate documentation and data management using corresponding IT system, including QMS softwares (TrackWise, ManGo), ERP (SAP), Discoverant…
  • Assure the timely delivery of required documents (plans, protocols and reports…) as defined in the project plan
  • Ensure that all process support activities are carried out at appropriate compliance levels
  • Participate to the establishment of raw material control strategy in relation with suppliers and the MSAT Raw material specialist

  • qualifications

    Who you are:

    • Degree in Biotechnology, Process Engineering, Pharmacy or related subject
    • Minimum of 3 years of experience in technology transfer, in R&D/Manufacturing environment
    • Demonstrated success record in leading project, in process improvements and interaction with other departments
    • Sound awareness of bio-pharmaceutical business
    • Sound awareness of GMP related issues and Health Authorities' requirements
    • Fluent in French and English

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LS

Laurène Soumahin

  • Randstad Merck Aubonne

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