Team Member Quality Control ( Analytical Method ValidationsTransfers)

Job Purpose

Team member for analytical method validations/transfers to handle product.

Should have knowledge and handson experience in Analytical Method Transfer (AMT) Method Validation and Method Verification.

Should have sound knowledge and experience in investigations and report preparation for Deviations and OOS.

Should have knowledge and handson experience in protocol and report preparation in DocHUB for AMT AMV and Method Verification.

Should have realtime working knowledge of LIMS and EMPOWER applications including chromatographic data processing.

Should have handson experience in handling HPLC GC and UPLC systems.

Should be able to independently plan and execute AMT AMV and Method Verification activities.

Should have handson experience in handling LCMS.

Qualifications :

Educational Qualification

• . in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry / Chemistry or equivalent

Experience

• 10-12 years of relevant experience in Quality Control or Analytical R&D within the pharmaceutical industry
• Proven handson experience in:
  • Analytical Method Transfer (AMT)
  • Analytical Method Validation (AMV)
  • Method Verification
• Exposure to regulated environments (USFDA EMA or other global regulatory agencies) is preferred

Mandatory Technical Skills

• Handson experience with HPLC UPLC GC and LCMS
• Strong working knowledge of EMPOWER software for chromatographic data handling
• Practical experience with LIMS
• Handson expertise in DocHUB for protocol and report preparation
• Sound understanding of ICH guidelines cGMP requirements and investigation processes

Additional Information :

Benefits Offered

At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.

The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture

Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.

For more details please visit our career website at Work :

No

Employment Type :

Full-time

Experience: years
Vacancy: 1