Manager /Assistant Manager - QC

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, instruments
• Candidate Should well familiar with Pharma Guidelines.
• Candidate should have good Verbal and Written Communication.