
Highly Skilled Functional Tester Wanted
16 hours ago
This position plays a crucial role in ensuring the delivery of high-quality systems that comply with industry regulations.
Main Responsibilities:- Leads validation efforts for Trackwise, Labware LIMS, and Documentum D2 platforms
- Develops and executes test strategies, protocols, and scripts to ensure system integrity
- Maintains regulatory compliance with GxP, 21 CFR Part 11, and other industry standards
- Conducts impact assessments and supports user acceptance testing (UAT) and defect triage
- Reviews system documentation and creates traceability matrices
Requirements include:
- Minimum 5 years of experience in QA/QC systems in life sciences/pharmaceutical domain
- Proficiency in Trackwise, Labware LIMS, and Documentum D2 platforms
- Strong understanding of validation lifecycle documentation (IQ, OQ, PQ)
- Knowledge of GAMP 5, FDA 21 CFR Part 11, and CSV best practices
- Excellent communication and documentation skills
Key Qualifications:
- Bachelor's degree in relevant field (e.g. computer science, engineering)
- Possession of relevant certifications (e.g. ITIL, Six Sigma)
Preferred Skills:
- Experience with automated testing tools and frameworks
- Knowledge of agile development methodologies
- Familiarity with cloud-based systems and technologies
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