QC - Officer/Sr.Officer

Macleods Pharmaceuticals; Dahej; On-site; INR 350,000 - 600,000; Full time

Job summary

Macleods Pharmaceuticals in Dahej, Gujarat seeks a QC professional to ensure cGMP, GDP and GLP compliance, uphold data integrity and safety standards in the QC lab. You will handle instruments, prepare analyses certificates, and support QC SOPs and validations.

The role requires meticulous documentation, instrument calibration oversight, and timely reporting of any OOS/OOT events, with hands-on work in HPLC, GC and wet chemistry techniques as part of routine QC analyses.

Qualifications

• Candidates must ensure cGMP, GDP, GLP, and data integrity compliance.
• Adhere to Safety norms and Good Documentation Practices (GDP).
• Handle laboratory instruments, glassware, chemicals and reagents with care.
• Prepare certificates of analysis for intermediates, raw materials, solvents and water.

Responsibilities

• Ensure compliance with cGMP, GDP, GLP, data integrity and safety principles within the section.
• Carry out lab safety responsibilities and work per safety norms.
• Handle laboratory instruments, glassware, chemicals, reagents, etc.
• Prepare certificates of analysis for various materials and water quality.
• Ensure QC activities and SOPs are followed.
• Perform method validation/verification transfers and related analyses (HPLC related).
• Maintain instrument usage logs and qualification/calibration records.
• Timely reporting of incidents or out-of-spec results to Section Head.
• Execute ERP/Trackwise/Caliber DMS/PLMS/Mac Portal transactions as authorized.
• Arrange and maintain documents (SOPs, specs, STPs, etc.).
• Troubleshoot QC instruments and equipment.

Skills

cGMP awareness

GLP compliance

Data integrity

SOP adherence

Tools

HPLC

GC

UV-Vis spectrophotometer

pH meter

Titration equipment

Thin Layer Chromatography

Refractometer

Conductivity meter

Job description

Job Description:-

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, Good 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.