ROLE
– Perform daily calibration of laboratory equipment
– Review lamp energy check, time synchronization check, temperature monitoring and compliance related activities
– Maintain laboratory equipment in proper operating condition and perform calibration as required
– Deliver consistent and precise results by following safety and GXP protocols/ SOPs/ regulatory guidance
– Associate with service/instrument engineer during routine preventive maintenance and troubleshooting/repair services
– Establish, execute and evaluate laboratory instrument calibration procedures and policies
– Prepare qualification protocol / report and compliance documents
– Prepare and execute Computer Systems Validation protocols
– Interact with Quality Assurance and service providers
– Prepare / revise Standard Operating Procedures
– Update lab compliance documentation system
– Create, update, review and manage Calibration, Preventive maintenance, and validation schedule
– Review Third-Party Documents / Certificate of Analysis
– Receive and manage controlled issued documents from QA Department
– Issue Laboratory notebook, Equipment logbook and Column usage registers
– Qualify in-house Working / Reference standard and impurities
– Assist for CSV activity with senior scientist
REQUIREMENTS
– Allied training of sophisticated instruments i.e. UPLC, HPLC, GC, ICP-OES, ICP-MS, Dissolution Apparatus etc.
– Knowledge of safety and GXP protocols/ SOPs/ regulatory guidance
– Ability to interact with Quality Assurance and service providers