Quality Assurance Manager in Switzerland

veröffentlicht
Kontakt
Barbara Sorce, Basel Professionals IT & Life Sciences
Jobtyp
festanstellung
Jetzt bewerben

job details

veröffentlicht
Ort
Switzerland
Sektor
Life Sciences
Jobtyp
festanstellung
Referenznummer
9629
Kontakt
Barbara Sorce, Basel Professionals IT & Life Sciences
Telefon
058 201 55 50
Jetzt bewerben

Stellenbeschreibung

Our client, a world-wide pharmaceutical industry specialized  in the synthesis of active pharmaceutical ingredients is looking for a  

Quality Assurance Manager

Location: Neuchatel area, Switzerland
Contract: permanent

Start date: asap

Tasks

  • Support the implementation and execution of the Quality Management Review process and to ensure compliance with ISO 9001 as well as local regulatory requirements.

  • Conduct of inspections / audits with Authorities (FDA, EMEA) and  clients

  • Management of internal and external audits (suppliers)

  • Assessment and follow-up of complaints, deviations, Change Control, OOS, CAPA

  • Drafting of protocols and validation and qualification reports, Site Master File, GMP Training, Annual Management Review, Product Quality Review (PQR)

  • Writing, modifying, reviewing and distributing the procedures (SOP) of the whole company

 

Requirements:

  • Master’s degree in Life Sciences, preferible Chemistry.

  • At least 3-5 years of in quality assurance within a GxP industrial environment such as Pharmaceuticals, Medical Devices, Biotech.

  • Excellent working knowledge/understanding of ISO and International Conference on Harmonization (ICH) Q8, Q9, Q10 requirements.

  • In-depth knowledge of current standards in the pharmaceutical (CGMP, ICH, USA CFR, GDP).

  • Knowledge in Regulatory affairs is an additional asset.

  • Fluent in both written / spoken French and English (proficiency in Italian would be an asset)

  • Strong customer focus, communication, presentation and interpersonal skills, to ensure cross-functional collaboration.

  • Self-motivated, result-oriented, proactive, purposeful, efficient and enthusiastic.

  • Fluent in both written / spoken English (proficiency in French would be an asset).

  • Flexible and can travel internationally up to 50% would be ideal.

  • Experience in conducting audits and in working on audit report submission and follow up would be preferred.

We are looking forward to receiving within your application:

  •  your CV in English
  • latest Work Certificates
  • your Motivation Letter  
  • ID/passport copy

 Apply now to be considered – Good to know you!

For more information and your application, please contact: Barbara Sorce, Team Leader Life Science Professionals,  M +41 79 376 00, barbara.sorce@ch.randstad.com