To follow all the SOP’s in Quality Control Laboratory. To follow the Good Laboratory practices and Good Documentation practices in Quality Control Laboratory. Sampling and analysis of Raw material/Packing material/In-process/ Intermediate/ Finished Product/Analysis of Stability samples/Swab samples. Operation and Calibration of various instruments like Balances, pH meter, KF & Autotitrator, Polarimeter, UV Spectrophotometer, IR, GC, HPLC etc. Handling of Working Standard/Reference Standard/Impurity Standards as per SOP. Maintenance of Primary Standard and GC Standard as per SOP. Review of Finished product, Raw Material, Stability, In-process and Intermediate Reports. Preparation of COA of Raw material, Intermediate, Finished product based on analysed data. To perform work assigned by supervisor/ QC Head. Initiation of Unusual, Incident, Deviation, OOS, CAPA. Review of chromatographic sequence, Instrument log book, standard usage log book. Column usage log book & in process data. Daily monitoring of temperature & humidity in controlled area. Preparation of method transfer analysis protocol from analytical method validation laboratory. To prepare the experimental observation & validation report. Maintenance of HPLC/GC column. Maintenance of records & documentation of analytical method validation. Support investigation under supervision of supervisor.Documentation must/ Regulatory company experience must.
