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Quality Assurance & Regulatory Affairs Manager

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Introduction :




Référence filiales : 204-FRIBOURG
Nom du conseiller : Guéhi Christian
Nom de la filiale : 3
Adresse :
Rue de Romont 33
Fribourg
1700

Description de l'entreprise :
We are looking for a
Secteur d'activité : Chimie & Life Sciences
Quality Assurance & Regulatory Affairs Manager

Introduction :




Référence filiales : 204-FRIBOURG
Nom du conseiller : Guéhi Christian
Nom de la filiale : 3
Adresse :
Rue de Romont 33
Fribourg
1700

Description de l'entreprise :
We are looking for a
Secteur d'activité : Chimie & Life Sciences

Description:


Incumbent is responsible for the release of raw materials and finished products in a due term. In addition incumbent is responsible for maintaining the deviation/CAPA process as well as complaint handling system to ensure a systematic reporting of non-conformities and product problems and initiate appropriate investigations.Principal AccountabilitiesResponsible for the market release process (technical release) and responsible for the storage of technical release documentation as well as retention samplesResponsible for handling nonconfrorming productsResponsible for complaint handling process Support handling of complaints and any other technical problems.Responsible for QA follow-up of laboratory investigations (OOS) in collaboration with QC ManagerParticipation in internal audit-program functioning as internal auditor.Responsible for the product-related nonconformity handling process and the related CAPA subsystemResponsible for the evaluation and approval of product-related changesFollow-up of corrective actions which have been identified in non-conformity reports or audits and to improve processes within the QA department.Supports the proper implementation and documentation of all product-related changes.Incumbent is responsible to motivate his subordinates in a safe and healthy working environment in his department. The incumbent shall have a good knowledge of the current applicable version of ISO 13485. He / She shall be familiar with the European Directive 98/79/EC, European Regulation IVR 2017/746 as well as CFR (Code of Federal Regulations) Title 21, part 820 and part 660 subpart D.
Date d'entrée : 27-01-2020
Type de société : Entreprise privée
Reference : 173815-31-10
Date de publication : 2020-01-24 17:09:26
Profil recherché :
A bachelor's or master's degree in pharmacy, biology, pharmacology clinical medicine or related life science is requiredLanguages: German, english & frenchMinimum of 7 years' experience in the biotech or pharmaceutical industry, with at least 3 years in RegulatoryExperience in leading and managing teams, setting clear direction, holding people accountable and fostering a collaborative team environmentCandidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product developmentExperience working within the regulatory affairs & quality assuranceExperience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategiesDemonstrated experience in working with multiple stakeholders

Pays : Suisse
Lieu de travail : Fribourg
Code postal : 1700
Catégorie : Affaires réglementaires;Biologie / Biotechnologie;Direction / Direction de projet;Pharmaceutique
  • Niveau d'études :
  • Expérience professionnelle :
  • Début du contrat : 27.01.2020
  • Durée du contrat : Non précisé

  • Conclusion :
    Send us your application.

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    Website http://www.manpower.ch

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