Ensure compliance to cGMP and safety standards in QC Laboratory.
QC samples analysis (i.e. in-process samples, finished product samples, Stability sample, Process validation samples, Raw material etc.) as allotted for testing using HPLC, GC instruments etc. as per protocols and standard test procedure.
Ensure receiving and entry of samples in Sample receipt register, received through I PQA.
Conduct lab investigations for OOS, 00T, laboratory incidences and deviations.
Timely closure of OOS, 00T, laboratory incidences and deviations in CQMS.
Provide trouble-shooting support to analysts in the lab.
Conduct work planning and work allocation to QC analyst for sample testing.
Provide training to Staff on SOPs and cGMP standards as and when required.
Document analytical data; calculate results and results feeding in SAP.
Assist with reporting and verification of test results/ reports.
Ensure integrity, accuracy and adequacy of the analysis performed.
Ensure timely completion of all assigned trainings in I-MS.
