Qualification and Validation Manager

Exciting new role at one of the top pharma companies in Basel, Switzerland!

This company is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Job Responsibilities :

You will be driving our recently commissioned Sterile manufacturing units to sustainable operations. It will include equipment, utilities, facility compliance as well as cleaning and sterilization processes validation.
Our multipurpose clinical manufacturing unit was designed for development and manufacturing of liquid dosage forms including steriles from early to late stage development approaching commercial. 
You will integrate our facility compliance team and work in close collaboration with our operations personal tying manufacturing processes to compliance requirements. 

Role and responsibilities will include:

• Manage Equipment cleaning and sterilization processes verification / validation
• Manage Qualification and maintenance of manufacturing environment (Clean class A, B, C, areas)
• Manage  qualification strategy, responsible for protocols, execution, and report for equipment and utilities (HVAC, Compressed air, Water For Injection, Filling line, autoclave, Rabs, inspection cabinets...)
• Responsible for Establishing preventive maintenance plans for equipment and utilities
• Suppliers management (equipment, utilities), including contracts covering Preventive maintenance , calibration.
• Write and update Standard Operating Procedures 
• Trouble shooting and investigations in line with cGMP relevant documentation (management of deviations or change controls or CAPAs)
• Internal and external audits (preparation, subject matter expert, follow up)

Requirements :

• Master's degree with minimum 10 years of working experience in qualification of facilities, utilities and equipment (HVAC, clean rooms) for sterile environment
• Experience in equipment cleaning/ sterilization processes validation, risk assessment
• Expert in Good Manufacturing Practices 
• Advanced knowledge in liquid filling (syringes and vials) or aseptic production and aseptic practices
• Advance knowledge in maintenance and engineering for production lines
• Knowledge in automations and Computerized systems
• Languages: fluent English both written and spoken, German and French are advantages
• Team spirit, good communication skills and ability to work with multi-disciplinary team including external suppliers and scientists 
• Willingness to work in sterile environment (with respective clothing, hygiene and behaviour requirements for grade A and B)