- 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 good laboratory practice.
Preferred candidate profile
- Candidate Should have Exposure of Pharma Injectable Plant.
- Adequate knowledge of GLP, audit compliance and Guidelines with strong communication skills.
- Trouble shooting on pharma related softwares, instruments
- Candidate Should well familiar with Pharma Guidelines.
- Candidate should have valuable Verbal and Written Communication.