Extractables Specialist

4 days ago

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

The primary role involves Extractable and Leachable (E&L) risk assessment for materials based on supplier information, determining the risk level and updating the Risk assessment accordingly.

  • Comprehensive knowledge of chemical and physical properties of MOC materials is essential for this role.
  • A detailed understanding of E&L guidelines, SOPs, Pharmacopoeia and ICH standards, USP 665 & USP 1665, is required for effective performance.

Additionally, expertise in Extractable studies, their methodologies, analytical strategies, and design is necessary to perform the responsibilities effectively.

Required Skills and Qualifications
  • Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry or equivalent science streams is a minimum qualification.
  • Minimum 8 years of experience in MS&T or manufacturing of pharmaceutical drug substance and product for Small and Large molecules is required.
  • Familiarity with regulatory guidance on ICH Q3, Validation, Product filing, and Post approval changes is a must.

Also, proven project management experience in a cross-functional environment, such as multi-site, technical development, and other functions, is essential for success in this role.

Benefits
  • Detailed understanding of E&L risk assessment for materials and ability to update the Risk assessment.
  • Expertise in reviewing and writing technical reports.
  • Good communication, Presentation, and Interpersonal skills are required.
Others

This job requires proficiency in English (oral and written). Experience in coordinating with the development organization, Supply management, QC, and Production department is also required. Additionally, active participation in E&L taskforce and network meetings is expected.

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