Qualification & Validation Staff
2 weeks ago
Persyaratan
- Minimum D3 or bachelor (Engineering, Pharma, Chemical background)
- Minimum 1 years experiences in Facility and equipment Qualification and/ or validation of pharmaceutical company
- Familiar and hands on with equipment qualification life cycle (URS, DQ, IQ, OQ, and PQ
- Familiar and understand basic principle on Pharmaceutical equipment for Solid and Liquid Technology (FBG, Mixing/Blending, Compression, Coater, Packaging)
- Ability to write documents/ reports in English
Tanggung Jawab
- Develop qualification protocol and report
- Involve on shop floor during quallification activities.
- Preparing related document about Qualification activities (e.g. Qualification Plan, Qualification Protocol, and Qualification Report) according to the respective SOP
- Improve qualification system to support project qualification activities
- Active communication with in stake holder and cross function to ensure the time execution as plan
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