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Senior Offres d'emploi - Neuchâtel, NE

Dernière mise à jour : il y a 15 heures
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QA Senior Specialist

QA Senior Specialist

Gi Life SciencesNeuchâtel, CH
For our pharmaceutical partner, we are looking for a : .QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control rec...Voir plusDernière mise à jour : il y a 8 jours
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Senior Product Development Engineer

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QA Expert Senior

QA Expert Senior

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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...Voir plusDernière mise à jour : il y a 8 jours
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Technicien qualité laboratoire senior H / F

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Senior Auditor – Audit Corporates

Senior Auditor – Audit Corporates

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Manager, Senior Engineer I

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QA Expert - Senior

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For a major pharmaceutical company in the Neuchâtel area, we are looking for a 12-month temporary contract for two positions as : . QA Senior Specialist / External Manufactoring H / F.English - French ...Voir plusDernière mise à jour : il y a plus de 30 jours
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Randstad (Schweiz) AGNeuchâtel, CH
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Senior Data Analyst

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(Senior) QC Analyst.

(Senior) QC Analyst.

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Ensure Compliance : Adhere to cGMP, BPD, and EHS standards.Conduct QC Activities : Perform and oversee routine and non-routine quality control activities. Manage Deviations : Initiate and handle deviat...Voir plusDernière mise à jour : il y a plus de 30 jours
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QA Senior Specialist

QA Senior Specialist

Gi Life SciencesNeuchâtel, CH
Il y a 8 jours
Description de poste

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