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