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4 days ago
We are seeking an experienced Quality Assurance (QA) professional to lead our testing efforts. The ideal candidate will have a strong background in quality systems within the life sciences/pharmaceutical domain and excellent communication skills.
About the RoleThis is a challenging opportunity for a skilled Test Lead to oversee the validation and configuration of Trackwise, Labware LIMS, and Documentum D2 platforms in a regulated environment.
Key Responsibilities:- Develop and Execute Comprehensive Test Strategies: Design and implement effective test plans to ensure high-quality system delivery.
- Collaborate with Cross-Functional Teams: Work closely with QA, CSV, and business teams to guarantee accurate system validation and regulatory compliance.
- Lead Impact Assessments and UAT Support: Conduct thorough impact assessments, provide UAT support, and drive efficient testing processes.
- Maintain Up-to-Date Knowledge: Stay current with GxP, 21 CFR Part 11, and CSV best practices to inform testing approaches.
- 5+ Years of Experience: Minimum 5 years of experience in quality systems within the life sciences/pharmaceutical domain.
- Platform Expertise: Strong proficiency in Trackwise, Labware LIMS, and Documentum D2 platforms, with expertise in validation lifecycle documentation (IQ, OQ, PQ).
- Excellent Communication Skills: Excellent communication and documentation skills, with the ability to work effectively in global cross-functional teams.
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