Beschreibung
Job Responsibilities (description of the work):Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems & LabX (Mettler)
Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
Coordinate alignment of systems users from various company groups on validation and qualification documentation
Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
Job Qualifications:
7+ years of Lab Systems validation experience is required. 10+ years are desired
Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters; 2+ years’ experience with LabX method development and validation preferred.
Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
Understanding of Data Integrity concepts is required
Excellent communication and written skills required
Duration 6-12 months depending on site
Site: Vienna or Remote
Language: German