Global MSAT QMS Specialist

vor 1 Woche

Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

Your responsibilities:

  • QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective
  • Document & System Support: Provide operational support for Veeva Vault QualityDocs, manage the lifecycle of QMS documents and maintain standardized templates.
  • Inspection & Audit Support: Coordinate and track PTT owned CAPAs from Health Authority inspections and audits, ensuring the timely closure of all commitments.
  • Training Coordination: Manage training assignments via Cornerstone and act as the liaison between Global MSAT and the PTQ Learning Team.

Your background:

  • BS/MS/PhD degree (Preferably in Pharmaceutical Science or Quality System related fields)
  • Min. 3-5 years of experience in Quality Systems and GMP operations
  • Demonstrated experience with Quality Management Systems (QMS), specifically CAPA management and Change Control
  • Knowledge of MSAT (Manufacturing Science and Technology) or Engineering operations in a pharma setting
  • Proficiency with electronic Document Management Systems (e.g., Veeva Vault QualityDocs) and Learning Management Systems
  • Leadership: collaborative, matrix team leadership experience and decision-making skills. Network mindset as well as strong communication and negotiation skills enabling you to establish trustful and successful relationship

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