Team Member - Quality Control (Method Validation & Transfer)

3w3 weeks ago

Dr. Reddy's Laboratories

IN · Full-time · INR 1,200,000 – INR 1,800,000

About this role

Dr. Reddy's Laboratories is a leading multinational pharmaceutical company with a bold vision to accelerate access to affordable and innovative medicines. As a Team Member in Quality Control, you will play a critical role in ensuring the integrity of analytical methods for both API and finished products.

Your day-to-day work involves hands-on execution of Analytical Method Validations (AMV), Analytical Method Transfers (AMT), and Method Verification activities. You will independently plan and execute these activities, prepare protocols and reports in DocHUB, and handle troubleshooting of analytical methods during validation.

You will work within a regulated environment, applying your deep knowledge of investigations and report preparation for Deviations and OOS. Real-time working knowledge of LIMS and EMPOWER applications, including chromatographic data processing, is essential for success in this role.

This position offers the opportunity to provide guidance to colleagues and contribute to the company's purpose of reaching over 1.5 billion patients by 2030. You will be part of a team that values deep science, progressive people practices, and robust corporate governance.

Requirements

10-12 years of relevant experience in Quality Control or Analytical R&D within the pharmaceutical industry.
Proven hands-on experience in Analytical Method Transfer (AMT), Analytical Method Validation (AMV), and Method Verification.
Hands-on experience in handling HPLC, GC, and UPLC systems.
Hands-on experience in handling LC-MS.
Real-time working knowledge of LIMS and EMPOWER applications, including chromatographic data processing.
Sound knowledge and experience in investigations and report preparation for Deviations and OOS.
Exposure to regulated environments (USFDA, EMA, or other global regulatory agencies) is preferred.

Responsibilities

Handle troubleshooting of analytical methods during validation, along with preparation of protocols and reports.
Provide guidance to other colleagues on method validation and transfer activities.
Execute Analytical Method Transfer (AMT), Method Validation, and Method Verification for API and finished products.
Prepare protocols and reports in DocHUB for AMT, AMV, and Method Verification.
Conduct investigations and prepare reports for Deviations and OOS.
Independently plan and execute AMT, AMV, and Method Verification activities.
Operate and maintain HPLC, GC, UPLC, and LC-MS systems for chromatographic data processing.

Benefits

Work environment free from discrimination and committed to equal opportunity.
Opportunity to work for a purpose-driven, future-ready multinational company.
Be part of a team that values deep science, progressive people practices, and robust corporate governance.
Contribute to the mission of accelerating access to affordable and innovative medicines.