GMP Compliance Specialist - Basel, Schweiz - Randstad

    Randstad
    Randstad Basel, Schweiz

    vor 3 Wochen

    Randstad background
    TEMPORARY
    Beschreibung
    For our client, an international pharmaceutical company based in Basel, we are looking for a GMP Compliance Specialist (m/f/d) (LSW)

    General Information:
  • Start date: ASAP
  • Latest Start Date: 01. June 2024
  • Planned duration: 1 year contract
  • Extension: not likely
  • Workplace: Basel
  • Workload: 80% -100%
  • Remote/Home Office: at least 3-4 days per week onsite
  • Working hours: Standard
    The perfect candidate:
  • You have a Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences or operational experience in a GMP environment within the pharmaceutical industry. Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations (e.g., ICH Guidelines) and principles of quality systems is a plus.
  • You are fluent in German and have good verbal and written communication skills in English.
  • You have a detail-oriented and analytical mindset with the ability to identify
  • potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements.
  • You demonstrate excellent communication skills and the ability to collaborate efficiently with interdisciplinary teams in a dynamic environment.
  • You appreciate being empowered to make decisions in your own field of expertise and actively seek feedback from others.

    Tasks & Responsibilities:
  • Management of local and global compliance processes like GMP training, archiving, quality risk management, handling of multisite and local impact assessments
  • Being an expert and first level support for relevant quality systems (e.g. Cornerstone, Veeva OneQMS, QualityDocs, QRM,)
  • Managing changes and deviations, as well as corrective and preventive actions in consultation with QA
  • Provide expert support to monitor, update, and adapt the GMP-relevant document landscape within pCMC
  • Participating in the preparation and coordination of internal and health authority audits, as well as supporting the timely implementation of inspection findings
  • Collaborating with team members in a role based working environment, as well as building and growing relationships with customers and partners across functional boundaries
    Must Haves:
  • Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences
  • Operational experience in a GMP environment within the pharmaceutical industry
  • MS office / standard Google applications
  • Fluent in German, good verbal and written communication skills in English
  • Soft skills: detail-oriented and analytical mindset; ability to identify potential deficiencies, propose solutions,
    and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate
    efficiently with interdisciplinary teams in a dynamic environment.