Role & responsibilities
To monitor routine GLP activities in lab, involves in planning and execution of GLP related activities like preparation of Calibration planner, Preventive Maintenance planner, Preparation and review of SOP, STP, AWR.
Responsible for Qualification of Laboratory instrument/equipment.
Responsible for preparation of URS/Risk assessment of laboratory instrument/equipment.
To carry out execution and closure of laboratory QMS.
To conduct entire training related activity in lab.
To carryout daily calibration of laboratory instruments
Responsible for the planning and work allocation of analysts
Responsible for review of analytical data generated in lab.
Responsible to qualify newly joined analyst
Responsible to plan volumetric solutions shelf-life studies
Responsible for trending of OOC/incidents
Responsible to overview maintenance/ repairing of instruments and their AMC from external agencies.
Responsible for ensuring maintenance of working standards along with their COA as per positive laboratory practice.
Preferred candidate profile
Candidate Should have Exposure of Pharma Injectable Plant.
Adequate knowledge of GLP, audit compliance and Guidelines with solid communication skills.
Trouble shooting on pharma related softwares, instruments
Candidate Should well familiar with Pharma Guidelines.
Candidate should have valuable Verbal and Written Communication.