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 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, instrumentsCandidate Should well familiar with Pharma Guidelines.Candidate should have good Verbal and Written Communication.Skills Required
Glp, Laboratory Analysis, Stp, Sop, Quality Control