Qualification and Validation Manager

Location: 

Basel, BS, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in the Basel Area (Allschwil) in Switzerland - a European biotech hub - Idorsia 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.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for a Qualification and validation Manager for our sterile liquids and semi-solids Clinical Manufacturing Unit.

 

 

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)

 

 

What Idorsia offers

 

  • Exciting opportunities for development and professional growth within our dynamic organization
  • A collaborative and solution-oriented environment where you can make a difference
  • An innovative and open culture in a truly multicultural environment
  • A competitive salary and generous benefits


Work  Location: Allschwil- Basel Area

Country: Switzerland

Business Area: Pharmaceutical Development - GMP Clinical Manufacturing Units

Schedule: Fulltime

Job Type: Permanent

Job ID: 2592

 

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.