Quality Control Analyst At Orchidia Pharmaceutical
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About the job
Perform routine quality control testing of product samples to support plant operations, while maintaining instruments used in analysis, preparing all needed documentation and following all safety instructions needed to work in quality control labs.
Responsibilities:
Carry out Quality Control tests on different types of samples according to approved methods of analysis.
Release products from testing once all criteria are met, as specified in the procedures and testing specifications.
Maintain laboratory equipment in line with preventative maintenance schedules.
Provide guidance to the quality control team on the application of the internal and external regulatory requirements.
Develop and revise laboratory procedures in accordance with current testing guidelines and good manufacturing procedures.
Participate in validation processes of manufacturing sites and equipment through analysis of process validation and cleaning validation samples.
Perform analysis using analytical instruments, maintain instruments in good condition and perform regular checks on instruments when needed.
Prepare solutions required for analysis, and able standardize volumetric solutions.
Check and investigate all potential problems that could occur during the testing process and helping solve those problems that could create OOS results.
Implement and emphasize all lab operations according to data integrity principles.
Aware of basic knowledge of handling waste and dangerous substances and perform all operations accordingly.
The quality control analyst receive the BOM of the packaging materials after being reviewed from research and development department.
The quality control analyst shall review for its destination [export country] and this to be considered in the finished product analysis and COA issuance.
Implement waste and dangerous substance management procedures.
Store dangerous substances in line with set and applicable guidelines.
Report relevant near misses, incidents, and / or accidents in line with set procedures.
Work through, follow and adhere to safety instructions and requirements in chemist labs.
Work according to GLP, GMP and GDP rules.
19. Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
Qualifications
Bachelor’s degree in pharmaceutical science.
From 1 to 3 years of experience in the pharmaceutical quality control laboratory / HPLC / UV.
Able to carry out laboratory work in accordance with laboratory procedures.
Accurate generation, recording and presentation of test results.
Must have the ability to accurately execute protocols and prepare draft reports with supervision.
Ability to meet workloads and project deadlines.
Excellent English, verbal / written communication.