QA Senior Specialist

Vor 5 Tagen

Neuchâtel, Schweiz Gi Life Sciences Vollzeit

For our pharmaceutical partner, we are looking for a:

QA senior specialist

(temporary position)

Your mission:

  • QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control record management

Your responsibilities:

  • Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements
  • Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, Out of Specification (OOS) records, processes, methods, procedures, documentation
  • Recommending quality related improvements to the contractor
  • Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
  • Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
  • Manage change control requests.
  • Process product complaints.
  • Review, edit, negotiate improvements to, and approve contractor documentation (process and transfer validation protocol, investigation, deviation…)
  • Lead review of Annual Product Quality Review reports, as necessary. Edit, and negotiate improvements to contractor supplied Annual Product Quality Review reports.
  • Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
  • Participate in self-inspections as appropriate
  • Participate in external audits of contractor manufacturers and distributors as assigned

Your profile:

  • BSc or equivalent in scientific discipline
  • Min. 5 years’ experience in QA in a pharmaceutical industry
  • Direct experience interacting with FDA and/or EMEA
  • Experience interacting with external manufacturers
  • Language: English and French, German a plus

  • Qa Senior Specialist

    Vor 5 Tagen

    Neuchâtel, Schweiz Gi Life Sciences Vollzeit

    For our pharmaceutical partner, we are looking for a:QA senior specialist(temporary position) Your mission: QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control record management Your responsibilities: Manage contractor quality assurance activities to ensure product is...

  • QA Senior Expert

    Vor 5 Tagen

    Neuchâtel, Schweiz Randstad (Schweiz) AG Vollzeit

    JobdescriptionFor our client, an international company based in Neuchâtel, we are looking for a QA Senior Expert.General Information:Start date: ASAPEnd date: 31.07.2025Workplace: NeuchâtelWorkload: 100%Tasks and responsibilities:Responsible for Quality Assurance in the frame of activities all along the manufacturing and release process.QA representative...

  • Senior QA Expert

    Vor 4 Tagen

    Neuchâtel, Schweiz CK Group Vollzeit

    Job Title: Senior QA Expert - Contract Work Location: Neuchatel Country: Switzerland Duration: Till December 2025 Rate: Up to CHF55 per hour (8 hours per day/40 hours p/week) depending on experienceYour main duties as a Senior QA Expert will include:Ensuring Quality Assurance in the frame of activities all along the manufacturing and release process....

  • Senior QA Expert

    vor 9 Stunden

    Neuchâtel, Schweiz CK Group Vollzeit

    Job Title: Senior QA Expert - Contract Work Location: Neuchatel Country: Switzerland Duration: Till December 2025 Rate: Up to CHF55 per hour (8 hours per day/40 hours p/week) depending on experience   Your main duties as a Senior QA Expert will include:Ensuring Quality Assurance in the frame of activities all along the manufacturing and release...

  • QA Expert

    Vor 4 Tagen

    Neuchâtel, Schweiz Randstad Vollzeit

    Jobdescription Description: Services: The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert in the frame of routine GMP operations for Fill and Finishing area. He/she must ensure the quality of information reported within the various systems and documentation with respect to current...

  • Senior Manager QA/RA Projects

    vor 1 Tag

    Neuchâtel, Schweiz Gi Group SA Vollzeit

    For our partner in pharmaceutical industry, Gi Life Science is looking for a:Senior Manager QA/RA Projects(Permanent position) Your mission:·         Ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to support the site in...

  • Spécialiste Senior en Assurance Qualité

    Vor 4 Tagen

    Neuchâtel, Schweiz Gi Life Sciences Vollzeit

    Spécialiste Senior QAPour notre partenaire pharmaceutique, nous recherchons un : Spécialiste senior QA (poste temporaire) Votre mission : Activités de supervision des fournisseurs QA, y compris la révision des lots commercialisés et des produits médicamenteux finis, gestion des plaintes et des enregistrements de contrôle des changements. Vos...

  • MS DSP Laboratory Specialist

    vor 10 Stunden

    Neuchâtel, Schweiz Takeda Vollzeit

    Description About the role : The Manufacturing Science (MSci) department is the owner of the process hence this team of SME’s (Subject Matter Experts) is a key player for all complex issues or projects involving the product. MSci Laboratory Specialist DSP is SME (Subject Matter Expert) for the lab scale product/process at Neuchatel and...

  • Senior Engineer

    vor 1 Tag

    Neuchâtel, Schweiz Gi Group SA Vollzeit

    Gi Life Sciences is looking for its partner in the Canton of Neuchâtel a:SENIOR ENGINEER (MANUFACTURING COMPLIANCE)Permanent PositionYour mission:The Senior Engineer (Manufacturing Compliance) authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging...

  • Quality Project Manager

    vor 11 Stunden

    Neuchâtel, Schweiz Axepta SA Vollzeit

    Notre client, une entreprise pharmaceutique avec de beaux projets, recherche actuellement un Senior Quality Project Manager pour travailler sur des projets stratégiques de la compagnie situé sur le canton de Neuchâtel. VOS MISSIONS :- Être représentant pour les activités Qualité dans les projets clés du site, en coordonnant entre les équipes QA,...

  • Vision Engineer Fill Finishing

    vor 11 Stunden

    Neuchâtel, Schweiz Takeda Vollzeit

    Description About the role : The Vision Engineer Fill Finishing is responsible for the following installation: Manual Visual Inspection (MVI) Automatic Vision Inspection (AVI) Automatic trayloader (TL) How you will contribute : 2 phases are provided in this job: project and routine   For the project: Is primary contact...