Company: Lilly
Location: Bangalore, Karnataka
Industry Type: Pharma/ Healthcare/ Clinical Research
Job ID: R-67990
End Date: 30th July 2024
Key Responsibilities:
- Perform activities for the analysis of active pharmaceutical ingredients and dosage forms to evaluate stability and support clinical trial materials.
- Test raw materials and excipients; generate/review release and stability data.
- Qualify, verify, validate, and transfer analytical methods and techniques to manufacturing sites and third-party testing laboratories.
- Apply cGMP practices during routine testing.
- Lead or provide input to investigations using scientific techniques to resolve laboratory-related issues.
- Manage project deliverables to support multiple projects at various phases.
- Establish and maintain key relationships within BR&D and Testing Labs.
- Demonstrate proficiency in data review, analysis, reporting, interpretation, and trending.
- Participate in inspection readiness activities and support regulatory inspections.
- Author and track the implementation of change controls and other compliance requirements.
- Utilize technical writing strategies to ensure clear, concise, and complete content.
Candidate Profile:
- BS/MS in analytical sciences, or equivalent pharmaceutical degree with at least 3 years of relevant experience in the Analytical field.
- Fundamental knowledge of cGMP compliance requirements and regulatory expectations.
- Good documentation skills and ability to author and/or review standards, GMP guidelines, SOPs, templates, protocols, and other documentation.
- Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word, JMP) and ability to compile, summarize and present information to diverse groups.
- Familiarity with Microsoft Office Tools; skills in Power BI, Python, and database tools are nice to have.
- Ability to troubleshoot problems and identify solutions.
- Customer-focused attitude.
- Experience with a variety of root cause methodologies.
- Good interpersonal skills and ability to work effectively in a team-based environment.
- Demonstrated learning agility, creative thinking, and problem-solving skills.
- Highly flexible, adapting to changes in priorities, requirements, and processes.
- Proficiency in complex laboratory analysis, including chromatographic, spectroscopic, immunoassay, DNA, and/or microbiological assays.
- Ability to work in a lab environment and follow safety guidelines.
Experience: 3 years
Qualification: BS/MS in analytical sciences, or equivalent pharmaceutical degree
Application Instructions: Interested candidates should apply by the end date of 30th July 2024.
Contact Information: [Company’s website or relevant contact details]
This posting aims to attract qualified candidates who have a passion for science and a commitment to improving healthcare outcomes.