Quality Control Reviewer & Analyst

Immacule Life Sciences; Solan; On-site; INR 600,000 - 900,000; Full time

Job summary

Immacule Life Sciences in India is seeking a QC professional for injectable/sterile manufacturing with hands-on analytical testing experience. You will review data, ensure regulatory compliance, and support audits across the QA/QC lab. The role emphasizes instrument handling, strict data integrity, and timely reporting.

Experience in USFDA-regulated environments is an advantage, with 3–7 years in QA/QC. The position requires rigorous adherence to cGMP, GLP, SOPs and ALCOA+ principles in a

Qualifications

• 3–7 years of experience in Quality Control in pharma.
• Hands-on experience in analytical testing and data review.
• Exposure to regulatory audits and USFDA/compliant QA systems is advantageous.

Responsibilities

• Perform testing of raw materials, in-process, finished products and stability samples.
• Handle HPLC, GC, UV, FTIR, KF and other QC instruments.
• Review analytical data, worksheets, chromatograms and calculations.
• Ensure compliance with cGMP, GLP, SOPs and ALCOA+ principles.
• Handle OOS, OOT, deviation and CAPA investigations.
• Maintain QC lab documentation and instrument records.
• Ensure timely completion of testing and reporting.
• Support internal, customer and regulatory audits.
• Follow laboratory safety, housekeeping and data integrity requirements.

Skills

Analytical testing

Data review

OOS/OOT investigations

CAPA investigations

Regulatory audits readiness

Tools

HPLC

GC

UV

FTIR

KF (Karl Fischer)

Job description

Role & responsibilities

Key Responsibilities QC (Injectable Plant)

• Perform testing of raw materials, in-process, finished products and stability samples.
• Handle HPLC, GC, UV, FTIR, KF and other QC instruments.
• Review analytical data, worksheets, chromatograms and calculations.
• Ensure compliance with cGMP, GLP, SOPs and ALCOA+ principles.
• Handle and support OOS, OOT, deviation and CAPA investigations.
• Maintain QC laboratory documentation and instrument records.
• Ensure timely completion of testing and reporting.
• Support internal, customer and regulatory audits.
• Follow laboratory safety, housekeeping and data integrity requirements.
• Perform testing of raw materials, in-process, finished products and stability samples.
• Handle HPLC, GC, UV, FTIR, KF and other QC instruments.
• Review analytical data, worksheets, chromatograms and calculations.
• Ensure compliance with cGMP, GLP, SOPs and ALCOA+ principles.
• Handle and support OOS, OOT, deviation and CAPA investigations.
• Maintain QC laboratory documentation and instrument records.
• Ensure timely completion of testing and reporting.
• Support internal, customer and regulatory audits.
• Follow laboratory safety, housekeeping and data integrity requirements.

Preferred candidate profile

Candidates currently working in pharmaceutical injectable/sterile manufacturing facilities with hands-on experience in analytical testing and analytical data review are preferred. Exposure to regulatory audits and USFDA-compliant quality systems will be an advantage.

Experience

• 3-7 years of relevant experience in Quality Control.
• Candidates with experience in injectable / sterile pharmaceutical manufacturing plants will be preferred.
• Experience in regulated facilities such as USFDA-approved plants will be an added advantage.