Qc Analyst

Mankind Pharma; Sirmaur; On-site; INR 600,000 - 900,000; Full time

Job summary

Mankind Pharma is seeking a Quality Control Analyst to perform testing of raw materials, in-process samples, and finished products in accordance with specifications. You will operate HPLC, UV-Visible spectrophotometer, FTIR, dissolution testers, and pH meters, and use Empower, Lab Solutions, CDS, LIMS, and Excel for data management.

The candidate should have a B.Pharm/M.Pharm/B.Sc./M.Sc. in Chemistry or related field with hands-on HPLC experience and strong knowledge of GMP/GLP and data

Qualifications

• Degree in pharmacy or chemistry or a related field.
• Minimum hands-on experience in HPLC operation.
• Knowledge of GMP/GLP and pharmacopoeial requirements.
• Experience with laboratory data integrity and documentation.

Responsibilities

• Test raw materials, packaging materials, in-process samples, and finished products per specifications.
• Operate analytical instruments: HPLC, UV-Vis, FTIR, dissolution, pH meters.
• Manage data with Empower, Lab Solutions, CDS, LIMS and Excel.
• Prepare standards and samples; perform assay, related substances, dissolution, and content uniformity tests.
• Review chromatograms and records for accuracy and integrity.
• Maintain instrument calibration, qualification and preventive maintenance records.
• Investigate OOS/OOT deviations per SOPs and GMP.
• Ensure GLP/GMP compliance and data integrity.
• Support method validation, transfer, stability studies, and audits.
• Coordinate with QA and Production for timely release of RM and finished products.

Skills

HPLC operation

Troubleshooting

Data review

GMP/GLP compliance

Laboratory documentation

QA coordination

Education

B.Pharm, M.Pharm, B.Sc., or M.Sc. in Chemistry

Tools

Empower

Lab Solutions

CDS Software

LIMS

Microsoft Excel

Job description

Role & responsibilities

• Perform testing of raw materials, packaging materials, in-process samples, and finished products as per specifications and test methods.
• Operate analytical instruments including HPLC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, and pH Meter.
• Handle laboratory software such as Empower, Lab Solutions, CDS Software, LIMS, and Microsoft Excel for data acquisition, analysis, and reporting.
• Prepare standard and sample solutions and perform assay, related substances, dissolution, and content uniformity testing.
• Review chromatograms, analytical results, and laboratory records to ensure data accuracy and integrity.
• Maintain instrument calibration, qualification, and preventive maintenance records.
• Investigate OOS, OOT, and laboratory deviations in compliance with SOPs and GMP requirements.
• Ensure compliance with GLP, GMP, data integrity, and regulatory guidelines.
• Support method validation, method transfer, stability studies, and audit activities.
• Coordinate with QA and Production for timely release of raw materials and finished products.

Preferred candidate profile

• B.Pharm, M.Pharm, B.Sc., or M.Sc. in Chemistry or a related field.
• 26 years of experience in Pharmaceutical Quality Control.
• Hands-on experience in HPLC operation, troubleshooting, and data review.
• Strong knowledge of GMP, GLP, pharmacopoeial requirements, and laboratory documentation.