QC Validation

Analysis of samples for batch release, stability testing, comparative analysis, validation and other testing activities along with proper documentation as per approved STPs and approved protocols.

Support in investigation of Deviation, LIR, OOS or OOT.

Participate in training/ qualification/ validation of methods during technology transfer from R&D to QC as per schedule and to complete related documentation timely.

Perform verification/ calibration/ qualification/ monitoring activities of various QC instruments/ equipments as per schedule.

To support in internal as well as external audit compliance.

Responsible for general work place cleanliness, safety compliance, equipment management and adherence to all approved SOPs and GMP procedures.

To issue, prepare, revise, refer & maintain the documents and records timely (i.e. DRS filling, Logbook , column records and other regulatory and GMP documents)

Discard the samples as per respective standard operating procedure

Analysis and review of analytical data of all HPLC/UPLC related tests and to verify reagent preparation records

To prepare the documents like SOPs, STPs, DRS, raw data, protocol, report etc and sample distribution as per standard operating procedure.