India Job Openings

Lilly

PR&D Deviation Mentor

Indianapolis

FULL TIME

October 10, 2024

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.

The Deviation Mentor is a member of PR&D QA team and teaches, mentors and guides deviation investigations and analytical investigators.

The Deviation Mentor is also responsible for the PR&D Deviation Management training program including deviation investigators and approvers and serve as cross functional coordinator for the all the deviation review boards across PR&D. Participates in deviation reviews as needed. The Deviation mentor can also lead complex investigations. They participate in regulatory inspections and collaborate in the PR&D inspection readiness program and assist and advice the lead investigators, functional leaders and Quality Leaders in issue investigation matters. Network internally and externally for process harmonization and share learning.

The Deviation Mentor owns PR&D Deviation procedure and process including the related Quality System Documents. The deviation mentor is responsible for overseeing quarterly reports across PR&D and drives the implementation of continuous improvement initiatives.


Key Objectives/Deliverables
  • Deviation Procedure and Process owner, responsible for deviation related Quality System Documents,
  • Trained as a lead investigator, deviation assessor and approver. Including Private investigations.
  • Provide advice and guidance to lead investigators in deviation investigation and analytical investigations (assessment, quality impact evaluation, root cause analysis method), investigation write-up (technical writing), support data, effective CAPA, trends, etc.
  • Act as liaison and collaborate with Investigators SME to identify improvement opportunities (trends, reoccurrences, description, and investigation writeups)
  • Provide advice and assist deviation reviewers and approvers on issue investigation matters.
  • Can lead complex investigations.
  • Can Lead Private investigations, Data Integrity investigations.,
  • Can act as a technical reviewer for deviation investigations and analytical investigations.
  • Can approve deviation investigations, either as technical or quality approver, including observation deviations and moderate deviations.
  • Authors the Quality System Management Review related to deviations.
  • Presents metrics/status of deviations routinely to PRD QA management team.
  • Provide direction and influence as cross functional coordinator for the all the deviation review boards across PR&D.
  • Review of major and selected moderate, minor deviations prior to deviation approval.
  • Guide and participate in the review of deviation “Story Boards.”
  • Guide in the elaboration and participate in reviews of deviation trend reports.
  • Design and deliver deviations related to training programs.
  • Design and elaborate PR&D deviation and investigation metrics.
  • Collaborates in defining the PR&D comprehensive continuous improvement roadmap to ensure PR&D keeps up to date with regulatory expectations, industry best practices with regards to the deviation, non-conformities, and discrepancy management program.
  • Collaborates with Global Projects and Initiatives related to Quality Systems Management (QMS), including deviation projects and improvement initiatives.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and PR&D Goals.
  • Coach individuals on inspection interactions.
  • Collaborates in regulatory inspections, Lilly audits and self-inspections, assisting in the preparation of key quality and compliance topics for audit and inspection readiness.
  • Integrate global initiatives related to the deviation management program into PR&D quality standards and processes.


Minimum Requirements:
  • BS or MS in scientific or technical degree: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree
  • 3+ years of experience in pharmaceutical industry

Additional Preferences:
  • Experience in TS/MS, Engineering, QC and/or QA is preferred
  • Demonstrated successful cross-functional teamwork
  • Excellent technical writing skills
  • Strong Influencing Skills and interpersonal and teamwork skills
  • Strong self-management and organizational skills
  • Critical thinking skills
  • Good knowledge of c GMP, external Regulations and Lilly Quality Systems requirements
  • Excellent communication and interview skills,


Other Information:
  • Travel (domestic and international) may be required.


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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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