Facility Compliance Associate

Location: 

Basel Area- Allschwil, BL, 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 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 bring 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 Facility Compliance Associate for our sterile liquids and semi-solids Clinical Manufacturing Unit

 

Responsibilities : 

 

You will be part of a project to maintain the qualification and launch new products from our clinical manufacturing unit. The multipurpose clinical manufacturing unit was designed for development and manufacturing of liquid dosage forms including sterile from early to late stage development approaching commercial. You will integrate our facility compliance team and in close collaboration with operations personnel for tying up manufacturing processes with facility compliance activities. Role and responsibilities will include:

  • Developping, validating and maintaining cleaning and sterilization procedures
  • Qualifying and maintaining manufacturing environment as per room classification including utilities and equipment 
  • Writing of monitoring, sampling and qualification protocols, plans, Standard Operating Procedures and cGMP relevant documentation 
  • Supervision and coordination of rooms cleaning by external service provider
  • Execution of environmental monitoring, including sampling related to rooms. Utilities (e.g. WFI, Nitrogen, etc.), equipment and batches (viable and non-viable) manufacture.
  • Coordination, execution of monitoring activities including pest control, prevention of cross-contamination
  • Results analysis, trend and report of data according to cGMP 
  • Trouble shooting and management of deviation according to cGMP

 

Requirements :

 

  • Bachelor's degree with minimum 3 years of working experience in room and utilities sampling and/or testing of sterile facilities

  • Experience in equipment cleaning/ sterilization process validation, equipment qualification, risk assessment

  • Basic knowledge in liquid filling (syringes and vials) or aseptic production and aseptic practices

  • Good know-how of technical tools along with knowledge of software and computer tools, statistic knowledge is a plus

  • Fluency in English both written and spoken, German and French would be advantageous

  • 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: Basel Area - Allschwil
Country: Switzerland
Business Area: Pharmaceutical Development - GMP Clinical Manufacturing Units
Schedule: Fulltime
Job Type: Permanent
Job ID: 2189

 

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 would be informed in greater detail in due course.

Please note 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 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.