-Coordinate testing plan of the raw materials, semi-finished, finished products, validation sample and project sample according to plan, assure the test were carried out on time according to the analytical methods and pharmacopoeia requirements.
-Support the QC manager to carry out the investigation of OOS and assure the appropriate CAPA was made and implemented.
-Assure the analytical instruments in QC were maintained, validated/verified and calibrated on time. Assure the analytical method in were validated.
-Maintain the reference standards as well as the relevant documentation and record. Maintain the reagents and their records.
-Draft procedures, qualification protocols of the analytical instruments and the analytical methods. Perform the qualification and validation work.
-Implement stability study according SOP and finish stability report on time
Other works assigned by the leader.