The U.S. Pharmacopeial Convention (USP) Associate Scientific Liaison in Hyderabad, India
Roles and Responsibilities
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.
Associate Science & Standards Liaison:
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.
Job Category Chemistry & Scientific Standards
Job Type Full-Time