RQ of Utilities (WFI)
Process RQs (SIP, Bulk Sterilization, Autoclave)
Cleaning validation
Warehouse mapping
Filtration skids
Mixing tank
Washer qualification
Trending of Results
Data mining
LIMS queries
Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
Lead project validation activities, and provide basic guidance and direction to junior project engineer as required.
Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
Manage qualification execution and lead validation deviation investigation encountered in qualification
Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.
Able to manage cross function stakeholders, and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities.
Participate in site Validation Maintenance Program.
Support Change Implementation on site.
Any other tasks as and when assigned by Supervisor or Project Lead.
Requirements
Preferably 10 years and above of experience for a senior role
3-5 years of experience in mid-level role
* 0-3 years of experience in a junior role
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