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Quality Assurance Validation & Qualification Expert.

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  • categoria
    industria
  • Contatto
    Mélissa Peer
  • riferimento
    129085-39724

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dettagli di lavoro

Quality Assurance Validation & Qualification Expert - 9 months contract

Description:

An exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Engineer for our Biotech drug substance plant in Corsier-Sur-Vevey.

As an integral member of the Quality Unit, you provide QA expertise for Equipment Qualification (including Sterilization qualification), Process Validation, Cleaning Validation, Raw Material Qualification and Computerized System Validation.

The role consists of elaborating the qualification/validation strategies, review and approval of protocols and reports, participates to risk analysis, identifies gap and purposes remediation plan. You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics. You review and/or approve qualification/validation documents, risk assessment, SOPs and take quality decisions according to company standards.

The activities of the QA Expert cover all qualification/validation phases from Basic Design until 1st use of equipment/raw material. You ensure GMP compliance during all phases of qualification/validation.

Quality Assurance Validation & Qualification Expert - 9 months contract

Description:

An exciting new opportunity has arisen to join us as Quality Assurance Qualification & Validation Engineer for our Biotech drug substance plant in Corsier-Sur-Vevey.

As an integral member of the Quality Unit, you provide QA expertise for Equipment Qualification (including Sterilization qualification), Process Validation, Cleaning Validation, Raw Material Qualification and Computerized System Validation.

The role consists of elaborating the qualification/validation strategies, review and approval of protocols and reports, participates to risk analysis, identifies gap and purposes remediation plan. You act as Quality Subject Matter Expert on specific topics and participate in risk assessments and handle deviations on these topics. You review and/or approve qualification/validation documents, risk assessment, SOPs and take quality decisions according to company standards.

The activities of the QA Expert cover all qualification/validation phases from Basic Design until 1st use of equipment/raw material. You ensure GMP compliance during all phases of qualification/validation.

  • qualifiche

    Who are you

    • University or relevant engineering degree
    • Hands on experience of equipment Qualification/Validation in the pharmaceutical industry
    • 3 years' experience in a quality environment in pharmaceutical industry or equivalent
    • Knowledge in cGMP and health authority expectations
    • Good interpersonal skills, with a positive attitude and the ability to support his colleagues in a context of growth and changes
    • Good writing skills.
    • French & English written & spoken.

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MP

Mélissa Peer

  • Randstad Merck Aubonne

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  • Raw material Expert

    • Corsier-sur-vevey, Vaud
    • determinato
    Your Role · To manage all activities related to process raw material (cell culture media, chromatography resins, filters..)· To participate in or lead projects linked to raw materials: replacement, optimization, life cycle management, within agreed financial limits and agreed schedule, for all the biotech processes· To collaborate with MSAT laboratory for raw material studies, by contributing to the design of the experiments and the analysis of the resu
    data di pubblicazione: 15 Marzo 2023
    Your Role · To manage all activities related to process raw material (cell culture media, chromatography resins, filters..)· To participate in or lead projects linked to raw materials: replacement, optimization, life cycle management, within agreed financial limits and agreed schedule, for all the biotech processes· To collaborate with MSAT laboratory for raw material studies, by contributing to the design of the experiments and the analysis of the resu
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