in a GMP-regulated laboratory located in Singapore.
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.
About You
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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