Global MSAT Quality Systems Specialist

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Flexsis Schweiz Vollzeit

Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competences within the Interiman Group, we offer tailor-made solutions in personnel consulting.

For our client
Roche
in
Basel
, we are looking for a motivated and reliable (m/f/d)

Global MSAT Quality Systems (QMS) Specialist

The Perfect Candidate possesses a degree in Pharmaceutical Science and over three years of experience in Quality Systems and GMP operations. Essential knowledge includes MSAT, proficiency with electronic Document Management Systems, and fluent English communication skills.


• Start Date:


• Latest Possible Start Date: Depending on the candidate, we could consider


• Planned Duration of Employment: 2 years


• Extension: likely


• Workplace: Basel/ Kaiseraugst


• Workload: 100%


• Home Office: Home office limited to 1-2 days a week max

Tasks & 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.

Must Haves:

  • 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 relationships.
  • English fluent, German is a plus

Nice to Haves:

  • Experience in a global role or supporting global teams.
  • Proven technical writing skills with an ability to translate complex technical information into clear, compliant documentation.

Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other Simply click on "Apply now" and we look forward to receiving your complete application documents

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