JOB RESPONSIBILITIES
To execute the commissioning and qualification of testing machines, analytical equipment, instrumentation, and the laboratory computerized system.
Involved in Laboratory Equipment as well as Spreadsheet Validation.
To conduct periodic re-evaluation of all validated system/equipment in QC laboratories and accordingly plan for remediation activities based on necessity.
To support capacity expansion related activities for new production introduction to site.
To be in charge of analytical method validation and analytical method transfer
To develop validation documents and qualification / validation protocols.
JOB REQUIREMENTS
Possesses at least Diploma / Bachelor’s Degree in Life Sciences, Biomedical Engineering, or equivalent.
Have proven experience in handling commissioning, qualification process and analytical method validation in laboratory setting (equipment & computerized system), preferably 5 years of experience or above.
Good knowledge in GAMP requirement as well as USP <1058>.
Strong project management, analytical and troubleshooting skills.
Familiar with compliances for qualification and validation process as well as documentation.