QA Operations Manager (BBBH454573) Genève, Suisse
For our client specialized in pharmaceutical industry, localized in the French part of Switzerland, we are looking for a :
QA Operations Manager
Your responsibilities
- Act as the Qualified Person manufacturing and distribution activities
- Ensure authorized activities management and records accuracy and quality
- Ensure QMS implementation and maintenance
- Create, modify and maintain GMP, GDP, Quality system
- Handle of GDP Documentation, quality agreements
- Conduct internal audits: prepare annual audit plan and self-auditing
- Conduct external audits: suppliers, CMO and distributors
- Be the contact point for Swiss medic
- Be in charge of Customer qualifications, Change control, CAPA (Corrective and Preventive Actions)
- Handle complaints, deviations and returns: decide on the final disposition of returned, rejected, recalled or falsified products and approve any returns to stock
- Ensure risk management activities, recall management
- Ensure training plan
Your profile
- Master in Chemistry, Biotechnology, Life sciences or Pharmacist
- Minimum a 5-year experience in pharmaceutical industry, preferred in biotechnology
- Strong knowledge and experience with GMP, GDP (Good Distribution practice), EMA Guidelines. Experience with Swissmedic registration process and regulations (highly desired)
- Mandatory experience in quality, preferred as a QP
- Solid experience in effective usage of data analysis tools and statistical analysis
- Fluent in French & English
Your application
Please apply on-line. For more information, contact Ms Sophie Darthenay