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Safety Knowledge:- Material Safety Data Sheet (MSDS), General Laboratory Safety.

Primary Knowledge:- Ensure Compliance with cGMP, GDP, GLP, data integrity and Safety principles within the section. Quality Good Manufacturing practices, Good Documentation Practices, Data integrity, Standard Operating Procedure, Specifications, Contamination, Cross-contamination, Least count, Environment monitoring, Gowning, degowning, Valuable Laboratory Practices.

Instrument Handling & Analytical Practice: Pipetting, Analytical Balance, Wet Chemistry, P/W, Titimetry Analysis, pH Meter & It's Measurements, pH Meter & It's Measurements, Water Analysis, Specific Gravity, Conductivity Meter, Raw Material Sampling and Analysis, Particle Size Analysis (PSD) & BD, TD and Moisture Content, Refractometer, Thin Layer Chromatography, UV Spectrophotometer, Assay, Melting Point and Boiling Point, LOD & ROI, KF Titration, IR, Tablet Friability, Hardness and Physical Parameters, Disintegration Test Apparatus, Dissolution Test Apparatus, QMS, Stability, HPLC, GC.

Role & responsibilities :-

- Ensure Compliance with cGMP, GDP, GLP, data integrity and Safety principles within the section.
- Responsibility of laboratory safety and to carry out the work with safety norms.
- Handling of laboratory Instruments/ Equipment's and Glassware,



Chemicals, reagents, etc.
- Prepared of certificate of analysis for Intermediate, raw material, Recovered Solvents / Substances , By product, In-Process ,Purified/Potable/ Treated water and etc.
- Compliance of all QC related activities & SOPs/GTPs.
- Performed analysis of Analytical method validation/ verification/ method Transfer , analytical cleaning validation, Intermediate, Raw material, Recovered Solvents / Substances , By product, , In process, Purified/Potable/ Treated water and etc., for HPLC related activity performed
- Handling of working /references standard Qualification Data.
- Maintain instrument/equipment usage logbook.
- Timely reporting of any incident, Lab event, OOS, OOT result to the Section Head.
- To perform the transaction in ERP, Trackwise, Caliber DMS, PLMS and Mac Portal software as per authorization rights.
- Ensure require trainings & qualification is successfully completed before allocating/ assigning the activity QC employee.
- Arrangement of documents (SOPs, Specifications and STPs, etc.).
- Performed of equipment / instrument qualification and calibration related activity.
- Handling the trouble shooting of all QC instruments/ Equipment.

📌 QC - Officer/Sr.Officer (Dahej)
🏢 MACLEODS PHARMACEUTICALS
📍 Dahej