Deviation Mentor - Parenteral Manufacturing

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Job description

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:

The Deviation Mentor is a member of the IPM Quality organization that educates, mentors and guides deviation investigations and analytical investigators. The Deviation Mentor is also responsible for the training program associated to deviation system and may leads deviation review boards, participates in deviation assessment review pre-approval and post-approval. The Deviation mentor leads the site metrics related to deviation system. He/she can also lead complex investigations. They participate in regulatory inspections and collaborate in the site inspection readiness program and assist and advice the lead investigators, functional leaders and Site Quality Leader and Quality Directors in issue investigation matters.

Responsibilities:

• 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, CAPA establishment and effectiveness.
• Coach the deviation review board: review of deviations prior to deviation approval. Provide advice and assist deviation reviewers and approvers on issue investigation matters.
• Owns the elaboration and reviews of deviation trend reports.
• Facilitates the implementation of DRB Playbook at the plants and site level and connect plant /site metrics, trending and procedures with its implementation.
• Establishes linkages with network and global teams and participate in relevant forums, such as global deviation CoP, ensuring the communication and implementation of best practices within the site.
• Lead the review of the quality of deviation investigations (post-approval).
• Design and elaborate site deviation metrics. Participate in the review of plant deviation trend analysis.
• Integrate global initiatives and/or projects related to the deviation management program into the site quality standards and processes.
• Design and deliver deviations related to deviation management training programs.
• Escalate concerns/issues and develop mitigation plans.
• Trained as a lead investigator, deviation assessor and approver. Can act as a technical reviewer for deviation investigations and analytical investigations. Can approve deviation investigations, either as technical or quality approver, including minor and moderate deviations.
• Can Lead complex investigations.
• Ensures procedures, tools, and templates are in place (as applicable) for consistency and sustainability.
• Participates on plat /site CAPA effectiveness program evaluation.
• Ensures trends are timely identified and investigated to prevent recurrence.
• Coach individuals on inspection interactions.
• Collaborates in regulatory inspections, assisting in the preparation of key quality and compliance topics for audit and inspection readiness.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Basic Requirements:

• BSc or MSc in a scientific or technical degree (chemistry, biology, microbiology, engineering or equivalent scientific/technical degree).
• 5+ years of experience in deviation management and analytical investigation experience in pharmaceutical industry, parenteral manufacturing experience preferred.

Additional Skills/Preferences:

• Experience in TS/MS, Engineering, QC and/or QA is preferred with expertise on parenteral products manufacturing.
• Excellent technical writing skills.
• Strong Influencing skills and interpersonal and teamwork skills.
• Strong self-management and organizational skills.
• Demonstrated successful cross-functional teamwork.
• Critical thinking skills.
• Good knowledge of cGMP, external Regulations and Quality Systems requirements.
• Excellent communication skills.

Additional Information:

• This is an onsite role based in Indianapolis, Indiana.
• Travel (domestic and international) may be required (less than 10%).

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 ( ) 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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