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Validation and Qualification Lead
Job Responsibilities:
- Act as Validation and Qualification Lead on a large global laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
- 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 and documenting system use in user, admin, and maintenance SOPs
- Coordinate alignment of systems users from various company sites, including international sites, 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
- 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.
- 7+ years of Lab Systems CSV experienced is required. 10+ years are desired
- Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required
- Understanding of Data Integrity concepts is required
- Experience working with systems users from different sites is required. Experience with international sites is highly desired.
- Excellent communication and written skills required.
