
Lab Equipment Validation Consultant
3 days ago
You will be responsible for:
- Supporting the decommissioning of analytical instruments in a GMP-regulated laboratory, ensuring compliance with internal procedures and regulatory standards.
- Managing the qualification workflow of laboratory equipment as needed, with hands-on involvement in protocols and reporting.
- Drafting and reviewing decommissioning protocols and related documentation, aligned with GMP requirements and client-specific templates.
- Collaborating with vendors, QA, and client stakeholders to ensure smooth execution of decommissioning and qualification activities.
- Ensuring all documentation and reports adhere to Data Integrity principles (ALCOA+), GAMP5 guidelines, and current GMP regulations.
- Providing technical support and oversight during execution of decommissioning tasks, including removal, data migration/archiving, and closure activities.
- 5-7 years of experience in laboratory equipment validation/ CQV projects in GMP-regulated environments.
- Solid understanding of equipment lifecycle management, with specific experience in decommissioning activities.
- Background in usage, calibration, maintenance, and qualification/validation of analytical equipment and instrumentation used in biopharmaceutical QA, QC, R&D, or micro laboratory environments is required.
- Fluent in English (written and spoken); Mandarin Chinese is a nice-to-have.
- Strong communication and stakeholder management skills.
- Detail-oriented, organized, and capable of managing multiple tasks under tight timelines.
- Quality-driven mindset with strong ownership and accountability.
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