Microbiology and Validation Spv

6 days ago

Bogor, Indonesia PT. Reckitt Benckiser Indonesia Full time

1. As the coordinator and Quality SME regards to qualification documents such as User Requirement Specification (URS), Functional Specification (FS), Design Specification (DS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) protocol and report, and prepare Performance Qualification (PQ) protocol and report for new and existing equipment and system, as well the execution process
2. Support validation and process assessment related to GxP standard and Hygienic design guidance
3. Support to conduct microbiological analysis and Conduct method suitability and Analysis Method Transfer (AMT) as required.
4. Supporting on conducting Microbiology analysis of all incoming raw material, water analysis and finished good product and reporting the result

1. Minimum holds a bachelor degree in Microbiology, Pharmacy, Chemical Engineering or any related
discipline.
2. Having 2 - 3 years of relevant experience in validation testing for consumer goods, healthcare, food &
beverage, cosmetic, or pharmaceutical industry.
3. Have a good knowledge and understanding on GMP (Good Manufacturing Practice) and validation and
qualification, computer system validation, data integrity, and hygienic design.
4. Computer literate (Windows, Power Point, Excel).
5. English literate (reading, written, spoken).

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