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E&L Risk Specialist

2 weeks ago

Warangal Hyderabad Secunderabad Telangana Nizamabad, India beBeeExtractables Full time ₹ 1,04,000 - ₹ 1,30,878

Job Summary

We are seeking an experienced professional to join our team as a Extractables and Leachables (E&L) Specialist. In this role, you will be responsible for assessing E&L risks and developing strategies to mitigate these risks.

About the Role

The E&L Specialist will work closely with cross-functional teams to identify and assess E&L risks associated with various materials and products. You will develop comprehensive risk assessments, test protocols, and reports to ensure compliance with regulatory requirements.

Key Responsibilities

  • Risk Assessment: Develop and implement E&L risk assessments for materials and products to identify potential hazards and mitigate risks.
  • Test Protocol Development: Create and execute test protocols to evaluate the leaching tendency of materials and detect extractables and leachables.
  • Report Writing: Compile and analyze data from tests and develop comprehensive reports to communicate findings to stakeholders.
  • Collaboration: Work closely with cross-functional teams, including development, supply management, QC, and production departments, to ensure effective communication and collaboration.

Requirements

  • Education: Bachelor's degree in pharmacy, pharmaceutical technology, chemical engineering, biotechnology, chemistry, or equivalent science streams. Master's degree or equivalent experience is desirable.
  • Experience: Minimum 8 years of experience in MS&T or manufacturing of pharmaceutical drug substance and product for small and large molecules.
  • Skills: Proven project management experience in a cross-functional environment, expertise in reviewing and writing technical reports, good communication, presentation, and interpersonal skills, proficiency in English (oral and written).

What We Offer

We offer a dynamic and challenging work environment that fosters growth and development. As an E&L Specialist, you will have the opportunity to work on complex projects, collaborate with experienced professionals, and develop your skills and knowledge in the field of E&L.