quality assurance director à Lausanne

publié
contact
Coralyne Saint-Cirel, Genève Professionals Health Care & Life Sciences
type d'emploi
permanent
postuler >

job details

publié
lieu
lausanne, vaud
secteur
Life Sciences
type d'emploi
permanent
référence
11903
contact
coralyne saint-cirel, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

Responsibilities

? Implement internal policies, procedures and specifications as required for the execution of quality compliance for the project ? Define the strategy for review and approval of qualification, validation and engineering documents ? Prepare regular status updates for reporting progress, issues, safety, quality  ? Lead and manage a team in the quality compliance area ? Ensure that all SOPs are in place for facilities and equipment qualification / validation ? Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams ? Act as the main point of contact for all quality compliance key topics ? Prepare the site for regulatory inspections (Swissmedic and International)

 

Profile 

? Minimum 10 years of experience in a Quality Assurance in a Manufacturing Environment  ? Experience in Biological APIs is a must have  ? Thorough knowledge of biotechnological technologies, processes and clean utilities ? Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation ? Excellent team leader skills  ? Must speak English and French