Overall Responsible for monitoring of daily Quality Control activities for both plants 1 & 2.
2.
Responsible for all the activities conducted in accordance with cGMP and GLP norms and to ensure all
the Laboratory personnel’s follow the compliance as per GLP in quality control.
3.
Responsible for the approval of the Job
Description
and
assign
the
work
as
per
JD
to
all
QC
personnel’s.
4.
Responsible for approval of SOPs, GTPs, STS/STPs, Quality control Manual, analytical method
validation protocol, report and other documents.
5.
Responsible for review of Quality Management System i.e. OOS, OOT, OOC, laboratory incidents,
deviations, and change controls, Protocols & Reports etc.
6.
Responsible to ensure that the investigation of OOS, OOT, Lab Incident, Deviation carried out as per
SOP, appropriate CAPA shall be derived and implemented in QC.
7.
Responsible for review of Environmental Management System.
8.
Responsible for ensuring that Calibration and Qualification of all Quality Control instrument is done as
per defined schedule.
9.
Responsible for ensuring timely analysis and release of all Raw Materials, Packaging Materials, In-
process, Finish Products, Process validation, Method Validation and Stability Samples.
10. Responsible for approval of indents for QC related items.
11. Responsible for training and evaluation of need base trainings, planned and unplanned training to all
QC staff to develop SME’s.
12. Responsible for up gradation of Quality System in Quality Control Department as per cGMP and
cGLP requirement.
13. Responsible to handle the Audits and review of Audit compliance report and ensure correctness in QC.
14. Responsible to select and recruit competent technical manpower for QC lab.
15. Responsible to raise the laboratory equipment’s CAPEX as per the requirement.
