QA Manager Compliance

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 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.

 

Job Responsibilities

 

  • Support the set-up of a sterile manufacturing facility and ensure its compliance: environmental monitoring and microbiological quality, equipment and utilities qualification, SOPs, cleaning validation etc.
  • Manage, review and approve qualification & validation documents of GMP equipment (facilities and utilities)
  • Verify GMP/GDP compliance at third party service providers and within internal facilities, systems, equipment, with particular focus on sterile injectables, aseptic processing techniques and distribution of aseptic products
  • Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities (not project specific)
  • Write, review, and/or approve internal quality system SOPs and other GMP/GDP regulatory related documentation focusing on the sterile manufacturing unit.
  • Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP/GDP standards and for process improvement (QS document including Quality agreements with third parties)
  • Administer systems to monitor (KPIs), track, and trend regulatory compliance (e.g. deviations, CAPA, investigations, complain, change control etc.)
  • Management of quality documents including use of EDMS systems used for electronic records
  • Contribute to the execution of external GMP Audits and internal self-inspection programs
  • Promptly report critical self-inspection findings to the Responsible Person and Management
  • Support the preparation and conduct of Regulatory Authority Inspections
  • Monitor changes in quality regulations and initiate required activities to maintain compliance of the quality system
  • Support optimization of Idorsia's pharmaceutical quality system by preparing for the review of relevant Key Performance Indicators

 

Candidate’s Requirements

 

  • University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
  • Minimum 5 years experience in managing GMP compliance and qualification of a sterile manufacturing facility
  • Knowledge and understanding of drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects
  • Experience in the set up and operation of a manufacturing unit, specifically for the preparation of sterile injectables is mandatory
  • Excellent knowledge of relevant GMP/GDP and international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP and ability to interpret and implement quality standards
  • Ability to manage complex projects and prioritize workloads according to the project importance
  • Ability to pro-actively initiate and lead quality compliance activities
  • Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
  • Strong interpersonal and influencing skills
  • Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German or French

 

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
  • A competitive salary and generous social benefits

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Pharmaceutical Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1108

 

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.

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