Senior QA Manager CSV

Location: 

Basel Area- Allschwil, 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 company, 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 bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

We are looking for an enthuasiastic and motivated Senior QA Manager CSV to join our team !

 

Responsibilities :

 

  • Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with Idorsia requirements and, where appropriate, in accordance with regulatory requirements
  • Provide support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11
  • Provide support, guidance and advice with regard to IT Infrastructure qualification to comply with GxP requirements
  • Determine regulations that are applicable to a computerized system and need for validation
  • Apply advanced knowledge and experience to address complex issues
  • Review and/or create validation documents where appropriate
  • Act as a primary contact person between the computerized system project team and Pharmaceutical Development Department
  • Act as the Pharmaceutical Development representative with regard to the update of the internal computerized systems inventory
  • Perform and coordinate internal and external audits (e.g., vendor audit…) with regard to Computerized System Validation
  • Perform and coordinate external audits with regard to IT Infrastructure and services qualification
  • Agree on Corrective/Preventive Actions following audits and follow up on adequate execution
  • Perform vendor postal assessment
  • Support CSV QA Team Leader in the preparation of the audit plan and Validation Master Plan
  • Support CSV QA Team Leader in the preparation and the management of QS Documents relating to CSV QA activities
  • Manage internal tool(s) supporting CSV QA activities (electronic tool(s))

 

Requirements :

 

  • University degree with suitable qualification in the pharmaceutical industry area
  • Good knowledge and understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11
  • At least 7 years experience in Computerized Systems Validation (CSV)
  • Excellent written and verbal communication and interpersonal skills
  • Excellent command of written and spoken English
  • Ability to work as an individual or as part of a team
  • Ability to work under pressure and prioritize tasks
  • Reliable and conscientious

 

What Idorsia offers

 

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

 

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Quality Assurance

Schedule: Fulltime

Job Type: Permanent

Job ID: 1445

 

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.