PURPOSE OF JOB
The lab technician performs microbiological and physiochemical tests according to written validation protocols. Interprets results, completes and reviews laboratory data, and submits records for final approval
RESPONSIBILITIES:
1. Provide qualification/validation quality/compliance support comply with laboratory safety procedures and requirements of Sartorius Stedim
2. Perform Viability, Bacterial Challenge, Product Specific Integrity and Chemical Compatibility tests according to Sartorius Stedim SOPs and approved validation protocols
3. Performing in-coming material testing
4. Prepare strains, culture media, test solutions and reagents necessary for the performance of all laboratory tests
5. Handling of Biological Indicators, cultures, chemicals and test solutions according to government regulations and company SOPs
6. Retrieve the corresponding test template from the system and fill accordingly. Complete lab data form, interpret results and review
7. Inform lab manager of any deviations related to validation protocol execution
8. Initiate and complete any investigations related to deviation of validation protocols or out of specification results
9. Perform necessary cleaning and sanitizing of the lab and equipment after testing to keep the lab tidy
10. Daily check monitoring data of lab environment and temperature controlled equipment
11. Perform inventory control of consumables, standard reagents to ensure the safety stock
12. Perform qualification, calibration and maintenance of relevant equipment or device
13. Assists project management (feasibility check of validation studies)
14. Reviews validation protocols and validation reports
15. Assists in maintenance of Standard Operating Procedures, incl. writing and revising
16. Other tasks assigned by lab manager
REQUIREMENT:
1. Bachelor degree in Sciences/Engineering or Technical Science/Technological degree
2. 3-5 years’ work experience including filtration and microbiology testing knowledge
3. Experience in the pharmaceutical industry is a plus
4. Good understanding of GMP requirements
5. Demonstrable oral and written communication skills – fluent in both Chinese and English
6. Good knowledge of Microsoft Office Applications
7. Familiar with microbiological analysis testing and operating related equipment
8. Detail oriented personality
9. Self-sufficient, target oriented, well organized and self-motivated work style
10. Good communication skills
11. Experienced with project management and teamwork (ideally in a global environment)
12. Team and customer service orientated attitude
13. Ability to analyze and solve problems
14. Must be willing and able to travel internationally for extended periods
微信分享
