Quality Assurance Manager in Switzerland

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