Laboratory Technician

Laboratory Technician

PURPOSE

Support QC General Lead to perform review, analysis testing, testing result documentation, and provide technical expertise properly and correctly with maintaining agility following defined rules in the purpose of implementation Bayer and Authority regulations related to the Quality Control.

MAJOR TASKS & RESPONSIBILITIES

• Responsible for ensuring to follow safety regulations for each stage of work and play a role in supervising each other in terms of cleanliness and tidiness of the laboratory area in order to fulfill HSE aspects according to HSE assignment and responsibilities.
• Responsible for sampling as per scheduled that are under QC responsibility including but not limited to materials and its reserved samples, bulk drug product, utility, equipment, and environmental system (including documentation, review analysis data result, review trend data of environmental monitoring, and maintaining/archiving analytical report data).
• Responsible for testing all of samples that are under QC responsibility including but not limited to finished goods, commercial / post market stability, raw and packaging materials, microbilology, environmental monitoring samples as per scheduled (including documentation, review analysis data result, maintaining/archiving analytical report data, and providing its reserve samples).
• Responsible for analytical testing of initial cleaning and cleaning validation samples.
• Responsible for ensuring that QC instrument used is within calibration period, instrument troubleshooting, and ensure its maintenance program.
• Responsible for ensuring no overdue training and performing personnel qualification or becoming comparative for analyst qualification.
• Responsible for ensuring compliance on all aspect of analytical testing, documentation cleanliness and tidiness.

QUALIFICATIONS & COMPETENCIES

• Bachelor / Diploma degree on microbiology or pharmacy or chemistry (are preferred) or having high school background on chemistry/microbiology.
• Excellent leadership skills and capability.
• Able to work on shift model (if required).
• Able to read, analyze and interpret Bayer guideline and international/ global guideline, writing report, business correspondence and procedure manual in English.
• Ability to manage good work atmosphere among internal team and with other teams.
• Having experience 3 years in QC microbiology laboratory particularly related scheduling and laboratory investigation.
• Understands know how on current GMP as well as other relevant national and international regulation for pharmaceutical products.
• Computer literate for standard office operational.