Senior Extractables and Leachables Specialist

7 days ago

Hyderabad Secunderabad Telangana Nizamabad Warangal, India beBeeextractables Full time ₹ 5,00,000 - ₹ 8,00,000

**Job Title:** Senior Extractables and Leachables Specialist

We are seeking an experienced professional to join our team as a Senior Extractables and Leachables Specialist. In this role, you will be responsible for conducting extractable and leachable (E&L) risk assessments for materials based on supplier information and determining the risk level.

Key Responsibilities:

  • Conduct E&L risk assessments for materials based on supplier information and determine the risk level.
  • Develop and maintain a comprehensive material library backed by corresponding E&L test data.
  • Coordinate Extractables studies or product-specific leachable studies.
  • Prepare E&L Risk assessment, E&L testing Protocol and Report.
  • Compile E&L data and provide the information to Toxicologist for assessment.

Requirements:

  • Bachelor's degree in pharmacy, pharmaceutical technology, chemical engineering, biotechnology, chemistry, or equivalent science streams.
  • Minimum 8 years of experience in MS&T or manufacturing of pharmaceutical drug substance and product for small and large molecules.
  • Familiarity with regulatory guidance on ICH Q3, validation, product filing, and post-approval changes.
  • 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).

Benefits:

In addition to the above responsibilities, you will also have the opportunity to work with a talented team of professionals and contribute to the development of new products and processes.

If you are a motivated and experienced professional looking for a new challenge, please submit your application today.

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