
Senior Validation Specialist
2 days ago
We are seeking an experienced Senior Validation Consultant to join our team. This role requires a deep understanding of Laboratory Information Management Systems (LIMS), particularly Thermo Scientific Watson LIMS.
- LIMS Validation Expertise: Lead responsibility for validating LIMS, with a focus on Thermo Scientific Watson LIMS.
- Documentation and Testing: Prepare User Requirement Specifications (URS), develop functional test scripts, and perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
- Regulatory Compliance: Ensure all LIMS validation processes and documentation adhere to 21 CFR Part 11 compliance and other critical regulatory requirements.
Required Skills:
- At least 5+ years of experience in Thermo Scientific Watson LIMS validation or administration activities.
- Strong understanding of GMP, GDP, GAMP, ICH, USFDA, and MHRA regulatory requirements.
- In-depth knowledge of 21 CFR Part 11 compliance.
Benefits:
- Frequent opportunities for professional growth and development.
- A collaborative and dynamic work environment.
Others:
- Ability to travel domestically and abroad up to 50-75% based on project needs.
- Excellent communication skills for engaging with diverse stakeholders.
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