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Post : Intern GMP
Job Description
Main Purpose and Objectives of Position
As part of a multi-disciplinary team in BRD Analytical, the incumbent will provide support for GMP analytical testing (i.e., lot release and stability) for clinical trial materials, primary stability studies and technology transfers. Job responsibilities include Data Integrity review of analytical data for a variety of active pharmaceutical ingredients and dosage forms to evaluate stability, and support clinical trial materials; qualification, verification, and validation of analytical methods; transfer of analytical methods and techniques to third party testing laboratories; and reference standard support activities. These activities may include use of data and information in NuGenesis, Trackwise, Veeva Vault, and other systems.
Key Responsibilities :
• Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations. May participate in the development and review of procedures, policies, and training materials associated with the area.
• Demonstrates basic understanding of the following:
• Develops/maintains awareness and familiarity of ICH guidelines and other global regulations and guidance documents per GMP requirements
• Review of lot release and stability data for active pharmaceutical ingredients and pharmaceutical dosage forms in the LRL portfolio.
• Various analytical instrumentation and techniques (e.g., HPLC, CE, UV, various types of compendial testing)
• Demonstrates project management and other key analytical skills
• Develops and maintains successful partnerships with other Lilly scientists, regulatory representatives, QA representatives and third-party collaboration partners
• Author protocols and stability reports to support lot release and stability testing, dating, temperature excursions and registration of API and drug product.
• Ensures the accuracy of the data/information entered into IT systems.
• Experience with laboratory and stability systems/ tools in performing basic operations in common informatics tools.
Candidate Profile
• B.S. or M.S. in Chemistry, Pharmaceutics, Biochemistry, Biotechnology, or related field
• Fundamental knowledge of cGMP compliance requirements and pharmaceutical stability principles.
• Good documentation skills and ability to author and/or review standards, guidelines, SOPs, templates, protocols, and other GMP documentation.
• Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word) and the ability to compile, summarize and present information to diverse groups.
• Excellent communication skills and willingness to interact with laboratory personnel, contractors, and management.
• Ability to troubleshoot problems and identify solutions.
• Ability to influence and partner with individuals outside of a formal reporting relationship towards realization of team goals.
• Customer-focused attitude
Additional Information
Qualification : B.S. or M.S.
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
End Date : 25th March, 2023
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