Quality Control Validation

Immacule Life Sciences; Solan; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Immacule Life Sciences in India seeks a QC/Analytical Validation professional to coordinate method validation, verification and transfer for sterile injectables. You will prepare protocols, review reports, and ensure data integrity across validation activities.

The role requires 3–8 years of relevant experience, familiarity with ICH/GMP and collaboration with QA, Production and Regulatory teams in a quality-driven environment.

Qualifications

• 3-8 years of experience in QC/Analytical Validation in a pharmaceutical manufacturing environment, preferably sterile injectables.
• Experience coordinating validation activities and documentation.
• Familiarity with ICH, WHO-GMP, US FDA requirements.

Responsibilities

• Perform and coordinate analytical method validation, verification and transfer activities.
• Prepare and review Validation Protocols, Validation Reports and related analytical documentation.
• Develop and execute protocols for Method Validation, Verification, and Transfer.
• Support instrument qualification and calibration.
• Coordinate with QA, Production, R&D, Engineering and Regulatory Affairs.
• Ensure compliance with ALCOA+ data integrity and data integrity practices.
• Participate in internal audits and regulatory inspections.
• Review data, chromatograms and laboratory records.
• Maintain validation schedules and trackers.

Skills

Analytical method validation

Regulatory compliance

QC coordination

Tools

HPLC

GC

UV-Visible

Dissolution

FTIR

pH meter

TOC

Job description

Role & responsibilities

• Perform and coordinate analytical method validation, verification and transfer activities for sterile pharmaceutical products.


• Prepare and review Validation Protocols, Validation Reports and related analytical documentation.


• Develop, review and execute protocols for:


• Method Validation


• Method Verification


• Method Transfer


• Cleaning Validation QC analytical support


• Hold Time Studies


• Stability Studies


• Process/Media-related analytical testing, where applicable


• Perform analytical testing using HPLC, GC, UV-Visible, Dissolution, FTIR, pH meter, TOC and other laboratory instruments.


• Handle validation parameters such as specificity, accuracy, precision, linearity, range, robustness, LOD and LOQ, as applicable.


• Ensure compliance with ICH, WHO-GMP, US FDA and applicable regulatory requirements.


• Review analytical data, chromatograms, calculations, worksheets and laboratory records.


• Investigate OOS, OOT, deviations and atypical results related to validation/testing activities.


• Support instrument qualification/calibration and laboratory equipment validation activities.


• Coordinate with QA, Production, R&D, Engineering and Regulatory Affairs for validation activities.


• Ensure proper implementation of SOPs, specifications, STPs, pharma copoeial requirements and data-integrity practices.


• Participate in internal audits, customer audits and regulatory inspections and provide required documentation/evidence.


• Ensure compliance with ALCOA+ data integrity principles and good documentation practices.


• Review trends and prepare analytical/statistical evaluation of validation data.


• Maintain validation schedules, trackers and periodic review records.

Preferred candidate profile

3-8 years of relevant experience in QC/Analytical Validation within a pharmaceutical manufacturing environment, preferably sterile injectables.