Key Responsibilities:
- Perform calibrations according to in-house schedules and SOPs.
- Maintain and manage calibration standards.
- Ensure instrument qualifications are performed accurately.
- Prepare and revise operation and calibration SOPs.
- Ensure compliance with QMS systems.
- Operate and calibrate chromatography systems, spectrophotometers, dissolution testers, FTIR, balances, pH meters, and titrators.
- Utilize Waters Empower software for various analytical tasks.
- Sign off on results through Empower 3 and print to SDMS.
Required Knowledge and Experience:
- Sound knowledge of the following analytical instruments:
- Chromatography systems: Waters / Agilent
- UV Spectrophotometer: Shimadzu / Perkin Elmer / Agilent
- Dissolution Testers: Distek, Hanson & Agilent
- FTIR: Perkin Elmer & Shimadzu
- Balance: Mettler / Sartorius & pH Meters (Mettler / Metrohm)
- Titrators: Metrohm
- Hands-on experience with Waters Empower software.
- Familiarity with QMS systems.
- Knowledge of instrument qualifications.
Instrument Models:
- HPLCs: Waters (2690/5 & 2489/2998/2475/2414) & Agilent 1200/1260 Series
- IC: Thermo Dionex 3000/5000
- GC: Agilent 6890N/7890 & G1888/7697A & Perkin Elmer Clarus 680
Instrument Parameters:
- HPLCs / UPLCs:
- Flow Accuracy
- Column Oven / Sample Compartment Temperature Verification
- Precision
- Volume Accuracy
- Injector Linearity
- Injector Carryover
- GPV
- Dwell Volume Calculation
- Detector Linearity
- Wavelength Accuracy
- Drift & Noise
- Detector Sensitivity (RI, FLR & ELSD)
- Signoff through Empower 3 & Print to SDMS
- GCs:
- AS Reproducibility
- AS Linearity
- HS Reproducibility
- HS Linearity
- Flow Calibration
- Oven Temperature Verification
- FID / ECD / TCD Calibrations (Where Applicable)
