TRD Composer Technical Service Specialist (m/f/d)
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
jid773dd57ws jit1044ws jiy26ws
TRD Composer Technical Service Specialist in Basel Arbeitgeber: Aequor Consulting GmbH
Aequor Consulting GmbH bietet eine dynamische und unterstützende Arbeitsumgebung in Zürich, wo Innovation und Teamarbeit im Mittelpunkt stehen. Mit flexiblen Arbeitszeiten, einer Vielzahl von Weiterbildungsmöglichkeiten und attraktiven Mitarbeitervorteilen wie Rabatten auf Hotels und die Möglichkeit für Homeoffice, fördert das Unternehmen das persönliche und berufliche Wachstum seiner Mitarbeiter. Hier haben Sie die Chance, an vorderster Front der Cybersecurity-Technologie zu arbeiten und bedeutende Veränderungen in der Branche zu bewirken.
