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Post : Associate Scientific Liaison
• Performs technical and quality reviews of documents to ensure a high level of quality within the department.
• Manages and tracks efforts for continuous improvements.
• Develops and reviews SOP’s, Operation Manuals, and training documents.
• Assists in investigations of quality related issues resulting from customer complaints to include root cause analysis, corrective action identification, action planning, and implementation monitoring.
• Develops and implements a database for quality measurement and improvement. Monitors database and performs trend analysis to improve quality in daily operations.
• Supports the day to day operation of the reference standard stability program.
• Works with internal stakeholders to develop new and innovative standards for analytical analysis of biopharmaceutical products.
• Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.
• Ph.D. degree in Chemistry, Biochemistry, Biology, Pharmacy, or a related field and five (5) years, or M.S. degree and eight (8) years of relevant industry experience in quality assurance. An equivalent combination of experience and education may be substituted.
• Experience with conducting review of scientific and technical documents.
• Experience with reference standards development is a plus.
• A working knowledge of general analytical methodologies is required.
• Ability to write technical reports related to material characterization, references standard evaluations, and method development.
• Ability to establish and nurture relationships with individuals of varying backgrounds and learning styles.
• Ability to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.
• Strong presentation and communication skills (written and oral).
• Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
• Project Management skills. Must have ability to prioritize and manage multiple, concurrent projects with often long life cycles.
• Experience with, and knowledge of the USP-NF is preferred.
Location : Hyderabad, India
Industry Type : Pharma
Functional Area : Scientific Liaison
End Date : December 30, 2021