Experience in pharmaceutical company handling of instrumentation and calibration processes and hands on experience in handling QMS documentations.
Note : Only Formulation OSD background is eligible
Knowledge of various PLC, DCS, SCADA, HMI
To plan for preventive maintenance as per schedule for all equipments in manufacturing area and maintain its records along with history cards.
To perform calibration of instruments & ensure that all instruments (Pressure gauges, Digital Hygrometers, Temp. Indicators, Humidity sensor with indicators, control valves, flow meters pressure transmitter etc) are calibrated & working properly.
Preparation & review of all qualification documents for equipments. (DQ, IQ, OQ & PQ)
To look after QMS (Deviation, Incident, Change Control, Risk Assessment, etc)
Updated knowledge about the 21 CFR and GAMP 5
worked in regulatory approved organization , having experience in USFDA approved company
To ensure the ALCOA Data Integrity Checks.
To plan for preventive maintenance as per schedule for all equipment’s in manufacturing area and maintain its records along with history cards.
Preparation and Review of departmental SOPs
To ensure that the instrumental abnormalities are attended in a most productive manner so as to keep the down time to its minimum.
To prepare calibration schedule of all instrument and ensure that the schedule is followed.
To take follow up from external service providers for calibration & validation related activities.
To take follow up from external service providers for calibration & validation related activities.
To ensure that proper position and condition of instruments.
To check Temperature Mapping activity is performed as per schedule.
Knowledge of SAP system.
To look for HVAC & BMS system & their instrument related issues.
If any breakdown occurs in shifts co-ordinate with superior to arrange corrective action for its rectification.
Preparation of Critical spare l