รายละเอียดงานResponsibility:
- Environment control testing and monitoring
1 Preparing work instruction and procedure of microorganism and environment controlling testing
2 Establishing and carrying out the environment controlling test monitoring both of annual and routine plai (example; air sampling, particle count and swap testing).
3 Establishing and carrying out routine or new the bioburden on product and material monitoring.
4 Perform gap analysis for updating of new requirement following changing version of external documentstandards, regulation, testing method and customer requirements)
5 Filling the environment control record document.
6 Preventive action by evaluation for result environment and bioburden as it may be cause of deviation.
7 Issue NCR / observation report concerned environment issuing for routine and validation.
8 Reviewing root cause the corrective action for environment and bioburden 's nonconformity included justification, if applicable.
9 Investigation root cause and find out the corrective action for non-conformity of ETO sterilization routine process in term microorganism.
- Analytical laboratory
10 Updating work instruction and procedure for lab testing method in compliance with international standard. internal URGO's testing (Headquarters company) for microbial, physical and chemical testing includec stability testing.
11 Performing physical testing in product and material, if applicable. (example; dye penetration, adhesive power and sealing resistance)
12 Performing physical testing in product and material, if applicable. (example; dye penetration, adhesive power.
and sealing resistance)
13 Develop method testing, transfer laboratory testing method or validation method process from Headquarters company to internal or external lab service