GMP QA Coordinator

 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a GMP Quality Assurance Coordinator to join their Global Pharmaceutical Development Team. It is a 12-month contract, with potential extension, based in Basel.

 

Main Responsibilities:

  • eQMS Activities:
    • Management of Veeva, Reports, Binders etc.
    • Preparation of reports for trending and monitoring of Change Controls, Deviations, CAPA, OOS/OOE
    • Management of QA related Documents in Veeva
    • Write, review, and/or approve internal SOP’s and other, according to employee’s expertise
  • Managing archiving of paper-based documentation for the QA Department
  • Other administrative task, e.g. preparative work for internal Audits, Inspections from Health Authorities, Quality trending, conduction of trainings (e.g. Quality modules, GxP training etc.)
  • Support stakeholders within Veeva activities/issues
  • Support for Supplier qualification, Quality agreements issuance and/or process validation activities where needed
  • Write, review, and/or approve internal SOPs governing compliance related operations and other GMP/GDP and regulatory related documentation
  • Assist for the preparation of SAP Master Data, release transactions, extension of shelf life, etc
  • Promote GxP and Quality mindset at all levels within the organization

 

Qualifications and Experience:

  •  Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
  • Apprenticeship, college or university degree in Pharmacy, Chemistry or alternative technical/science
  • Minimum 3 years experience in Quality and/or Pharmaceutical industry
  • Knowledge and understanding of basics in drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects
  • Knowledge of relevant GMP/GDP and/or international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP
  • Ability to work on multiple projects with various disciplines and prioritize workloads according to the project importance
  • Attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent
  • Ability to pro-actively notice, report, and work on quality gaps and improvements
  • Ability to independently perform assigned tasks within given timelines. Timely communication of any anticipated delays to meet given timelines
  • Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German or French
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