Education / Experience
1. College or university degree.
2. Minimum 2 years’ experience in a testing laboratory environment, Master degrees can be exempted from the requirement.
1. GMP philosophy.
2. Equipment 3Q activities background.
3. Analytical method validation background.
1. Strong interpersonal skills.
2. Good at planning and execution.
3. Good at document management.
4. Good command of oral and written English.
5. Computer literate, knowledge of word processing and spreadsheet softwares.
Strictly follow procedure and responsible for the exercising of maximum care, good judgment and behaviors in preventing SHE incidents.
Co-ordinate with other shift teams to ensure that scheduled testing and release activities are completed in a timely manner with minimal delays. Perform shift and weekend duties if necessary.
Strictly follow approved test procedure with current authorized forms and ensure accuracy and integrity in raw data, calculations and results.
Investigate and document suspect or out-of-specification data regarding any analytical testing conducted in the laboratory.
Qualify, operate, calibrate and maintain laboratory facilities and instrument as schedule and procedure requirement.
Assist in maintaining adequate levels of reference standards, control samples, reagents, spare parts and GMP consumable, meanwhile, properly store them as requirement.
Assist in the training of new Analysts so as to enable them to carry out their duties in accordance with GMP.
Be accountable for method transfer/validation, and assist in the development and review of laboratory test methods.
Be knowledgeable with applicable policies, procedures and guidelines. To ensure continuous compliance to GMP and Wyeth quality system requirement in designated areas.
Execute all duties faithfully and responsibly in accordance to written procedures and to action report all observations of GMP non-conformances.
Perform or assist in additional job-related functions as directed by the supervisor.