
Regulatory Compliance Specialist
1 week ago
Transforming life sciences and healthcare through tailored solutions, we are dedicated to creating lasting relationships with clients and empowering individuals to reach their full potential.
We foster a culture of respect, value integrity, fairness, and the unique contributions of every team member. Our team is passionate about shaping the future of Life Sciences and healthcare through technology and innovation.
Job DescriptionYou will ensure compliance, validation, and quality assurance of Laboratory Information Management Systems (LIMS) in GxP-regulated environments. Your mission is to guarantee that LIMS implementations, upgrades, and operations meet international regulatory standards (21 CFR Part 11, EU Annex 11).
- Ensure LIMS compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
- Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or a related discipline.
- 3-7 years of experience in QA roles focused on computerized systems, preferably LIMS.
- Hands-on experience with LIMS platforms (e.g., LabWare, LabVantage, SampleManager, Thermo Fisher).
- Experience in computerized system validation (CSV) within a GxP pharmaceutical or biotech environment.
- Strong analytical, documentation, and problem-solving skills.
- Confident communicator, able to explain QA and validation principles to technical and non-technical stakeholders.
- Structured, detail-oriented, and quality-focused mindset.
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