Senior QA Manager CSV


Basel Stadt, 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 want to 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 bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,000 highly qualified specialists dedicated to realizing our ambitious targets.


We are looking for a motivated Senior CSV QA Manager to join our dynamic team !


Job Responsibilities


The Senior CSV QA Manager will:


•    Ensure the compliance of the Computerized system used within the company:

o    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
o    Determine regulations that are applicable to a computerized system and need for validation
o    Apply advanced knowledge and experience to address complex issues
o    Review and/or create validation documents where appropriate
o    Support efficient integration of the Data Integrity expectations during CSV activities
o    Deliver appropriate training to key stakeholders to develop and maintain the CSV and Data Integrity knowledges
o    Support CSV QA Team Leader in the preparation of Validation and Data Integrity Master Plan


•    Act as a primary contact person between the computerized system project team and Pharmaceutical Development Department

o    Provide support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11
o    Provide support, guidance and advice with regard to IT Infrastructure qualification to comply with GxP requirements
o    Act as the Pharmaceutical Development representative with regard to the update of the internal computerized systems inventory


•    Act as Lead Auditor to ensure the compliance along the Computerized system lifecycle:

o    Represent Idorsia during internal/external audits
o    Perform and coordinate internal and external audits (e.g., vendor audit…) with regard to Computerized System Validation and Data Integrity principles
o    Perform and coordinate external audits with regard to IT Infrastructure and services qualification
o    Agree on Corrective/Preventive Actions following audits and follow up on adequate execution
o    Perform vendor postal assessment
o    Support CSV QA Team Leader in the preparation of the audit plan 


•    Support CSV QA Team Leader in the preparation and the management of QS Documents relating to CSV QA and Data Integrity activities 


Candidate's requirements


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


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 social benefits

Work Location: Allschwil – Basel Area
Country: Switzerland
Business Unit: Quality Assurance
Schedule: Full-Time
Job Type: Permanent
Job ID :3301



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.