402 days ago on alpina-hr.com

Trackwise Solution architect/ Senior Developer (m/f)

Alpina HR-Services AG

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 Please refer to JobSuchmaschine in your application

Trackwise Solution architect/ Senior Developer (m/f)

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Alpina HR is looking for a Trackwise Solution architect/ Senior Developer (m/f)

Key Accountabilities:
- Assist in analyzing special requirements that may require development of new features, custom integration, or custom functionality
- Identifies and reviews regulatory standards such as 21 CFR Part 11 and shares with teams as needed to educate the teams on QMS requirements
- Works with project leaders and both internal and external (consultants) team members to ensure that all the development work on projects meets applicable ISO and CFR QMS requirements
- Reviews partner QMS procedures and other documents as requested to meet ISO and FDA QMS requirements
Hands-On experience on TW Installation, Upgrade and/or Migration
Should be able to recommend Hardware/Software/Architecture of TrackWise Landscape based on expected usage and other parameters


Key Competencies

- Sound knowledge about quality processes in pharmaceuticals such as Complaints Management, CAPA, Audit, Non-conformance, Management et al
- TrackWise Architecture: Environment, Servers
- TrackWise Configuration: Workflows, States, Activities, Data fields, Selection Values, Group Categories, Projects, Migration
- Coordinator Configuration: Admin Queries, Admin Triggers, Dynamic Queries
- TrackWise Utilities: PR Import, Selection Import, Person Import, Entity Import
- TrackWise user access management – Person, Login Accounts
- Crystal Reports with TrackWise
- Electronic Reporting (eMDR/eMDV/E2B)
- Experience with MS SQL database solutions; experience with Oracle database solutions is a plus
- Familiarity in working with Crystal Reports and Information Builder solution is a plus.
- Knowledge of SOAP and REST based web services technologies is a plus
- Experience in Pharmaceutical Manufacturing and QA is a must

If you are interested in this project, please send us your CV as a Word file and a phone number where we can reach you at info@alpina-hr.com