At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, USA. Our 39,000 employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
The Product Research and Development (PRD) organization strives to develop and deliver quality medicines to patients. The portfolio consists of development and commercialization of insulins, small molecules, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy systems. This organization is a multidisciplinary group that works collaboratively with therapeutic business units and manufacturing to deliver the incredibly exciting Lilly clinical portfolio to patients around the world.
The Lilly Capability Centre India (LCCI) located in Bengaluru India is a strategic investment made by Lilly to attract top talent from the vibrant academic and professional environment in India and deploy them to develop and enable critical capabilities for Lilly. The LCCI group in India houses a PRD team that works closely with the PRD team in Indianapolis in enabling the delivery of Lilly’s portfolio.
Responsibilities and Skillsets:
- The Document Controller (DC) will process documents utilizing current electronic system (Veeva, QualityDocs) that support analytical testing, development, and characterization activities for process and product development, clinical trial materials, primary stability studies and technology transfers.
- Assist customers with processing documents/NuGenesis requests. Resolve issues with document and NuGenesis processing and escalate to appropriate Lilly staff when needed.
- The DC is to follow good documentation procedures and established business practices to complete daily tasks. They are also to follow PRD procedures including laboratory practices related to documentation and NuGenesis.
- Train and maintain 100% compliance with all applicable business processes and PRD Procedures. Complete and maintain Veeva DC and NuGenesis DC training.
- Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations.
- Ensures the accuracy of the data/information entered into IT systems by demonstrating appropriate attention to detail.
- Demonstrated knowledge, experience with MS Office products.
- Upload new documents into Veeva Vault QualityDocs and populate document properties
- Create the QualityDocs workflow for document approval
- Monitor workflow status (including follow up if any delay is noted) and set effective date after document approval
- Follow the local standards for documentation practices and record retention
- Reference and update the guidance documents
- Generate process metrics as required
- Respond to all phone calls, instant messages, and emails regarding QualityDocs system and process questions
- Respond to all client issues regarding the collaboration site used to submit documents to be routed in QualityDocs
- Escalate issue if appropriate document formats and conventions are not followed
- Train new employees on processes and local procedures once proficient with duties of a Document Controller
Other key responsibilities:
- Work during operating hours in US -Eastern Standard Time
- An understanding or knowledge of laboratory techniques and analytical testing.
- Experience with, Veeva Vault QualityDocs or a similar Electronic Document Management System, NuGenesis (includes SDMS, ELN, Sample Management) or similar Laboratory Information Management System.
- Proficiency with existing Microsoft products and platforms, including Excel, Word, Sharepoint, OneNote, Teams, including Outlook.
- Excellent communication skills: the candidate will work directly with multiple scientists
- Organizational skills: the candidate will handle multiple tasks daily and track to ensure tasks are completed
Educational Requirements:
- Bachelors in pharmacy or science with 0-3 years of experience in the development area of a pharmaceutical organization focussing on documentation and compliance.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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