TRD Composer Technical Service Specialist

Aequor Consulting GmbH

Basel

À distance

CHF 120 000 - 160 000

Temps partiel

Il y a 6 jours
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Avantages offerts par ce poste

Remote
5 weeks of annual leave
Certification costs
Discount card CHF 2400
Fitness contribution CHF 400

Résumé du poste

Aequor Consulting GmbH in Basel seeks a TRD Composer Technical Service Specialist to advance regulatory IT systems, manage data governance and coordinate technical integration with IT and business stakeholders. You will implement SUAM 3.0 into TRD Composer, set up GSRS interfaces, maintain substance data models and ensure alignment with GMP and IDMP standards.

Strong English communication and hands-on TRD Composer expertise are essential; the role offers 80-100% workload, remote work, and a

Qualifications

  • Hands-on TRD Composer expertise and understanding of its purpose and functionality.
  • Experience with regulatory processes and documentation in the pharmaceutical industry (GMP familiarity).
  • Knowledge of IDMP standards and ISO standards in digital regulated environments.
  • Understanding of IT systems, interfaces, data models and data governance.

Responsabilités

  • Coordinate the implementation of SUAM 3.0 into TRD Composer with NVS IT Production.
  • Set up the GSRS application and develop interfaces between GSRS and TRD Composer.
  • Create and maintain the TRD reference data model for substance information.
  • Coordinate the TRD Data Governance organization and support data management processes.
  • Coordinate technical implementations and system changes with IT and business stakeholders.
  • Support change-related activities per IT documentation and change management processes.
  • Ensure alignment between technical requirements and regulatory documentation needs.

Connaissances

TRD Composer
Regulatory documentation
Data governance
Stakeholder coordination
English communication

Outils

GSRS

Description du poste

TRD Composer Technical Service Specialist

Aequor Consulting GmbH Vacant since : 20.10.2026 4057 Basel (BS) 80% - 100% By agreement Temporary

For our client in the pharmaceutical industry, we are looking for a technically skilled professional with proven experience in TRD Composer, regulatory documentation and pharmaceutical data management. In this role, you will play a key part in the integration and further development of regulatory IT systems, while coordinating data governance activities in a highly regulated environment.

Responsibilities
  • Coordinate the implementation of SUAM 3.0 into TRD Composer in collaboration with NVS IT Production
  • Set up the GSRS application and develop interfaces between GSRS and TRD Composer to enable the exchange of substance information
  • Create and maintain the TRD reference data model for substance information
  • Coordinate the TRD Data Governance organization and support consistent data management processes
  • Coordinate technical implementations and system changes with relevant IT and business stakeholders
  • Support change-related activities in accordance with internal IT documentation and change management processes
  • Ensure alignment between technical system requirements and regulatory documentation needs
Requirements
  • Proven hands-on experience with TRD Composer and a thorough understanding of its purpose, design and functionality
  • Experience with regulatory processes and documentation requirements in the pharmaceutical industry, particularly health authority documentation and/or Manufacturing Practice (GMP)
  • Knowledge of IDMP standards and relevant ISO standards, including their application in digital processes within a regulated development environment
  • Understanding of IT systems, application interfaces, data models and data governance
  • Experience working with pharmaceutical substance data; familiarity with GSRS is an advantage
  • Knowledge of IT documentation and change management processes in a regulated pharmaceutical environment
  • Strong technical understanding and the ability to follow programming concepts and system integration requirements
  • Excellent English communication skills, with strong coordination, stakeholder management and leadership capabilities
Benefits
  • Remote
  • 5 weeks of annual leave
  • Coverage of certification costs
  • -Card with a 20% discount on up to CHF 2,400
  • CHF 400 contribution towards a fitness membership
  • Aequor Consulting GmbH
    Haltingerstrasse 101
    4057 Basel

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  • Work location 4057 Basel (BS)
  • Workload 80% - 100%
  • Employment start By agreement
  • Employment duration Temporary
  • By online Online form
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