India Job Openings
Lilly
Sr. Principal Associate- API EM Quality
Indianapolis
FULL TIME
October 31, 2024
Position Brand Description:
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world.
The API EM Quality Sr. Principal Associate provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Sr. Principal Associate’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to c GMPs and regulatory commitments. The Sr. Principal Associate will need to interact daily with a wide variety of people, primarily external partner’s team members and site management.
Key Objectives/Deliverables:
- Serve as a quality liaison between CMs and Lilly.
- Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
- Escalate quality issues at CMs to Lilly QA management.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Provide quality oversight of Lilly/API-EM Quality Plans.
- Coordinate and perform QA responsibilities of API shipments.
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
- Participate on the Technical Review Board.
- Evaluate and disposition API batches, if required.
- Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
- Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
- Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
- Ensure all processes are in an appropriate state of control.
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
- Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
- Participate in APR activities.
- Participate in projects to improve productivity.
- Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
Basic Requirements:
- BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences
- At least 5 years of Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing
Additional Preferences:
- Experience in quality support for Quality Control activities
- Thorough technical understanding of quality systems and regulatory requirements
- Knowledge of pharmaceutical manufacturing operations
- Demonstrated coaching and mentoring skills
- Experience in root cause analysis
- Demonstrated application of statistical skills
- Demonstrated strong written and verbal communications skills
- Strong attention to detail
- Proficiency with computer system applications
- Excellent interpersonal skills and networking skills
- Ability to organize and prioritize multiple tasks
- Ability to influence diverse groups and manage relationships
Other Information:
- Must complete required training for API EM Quality Assurance
- No certifications required
- Must be able to support 24 hour/day operations which may require support outside of normal working ours
- This is NOT a remote position and requires on-site presence
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.
#We Are Lilly
New Job Alerts
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
ADIENTONE INDIA PRIVATE LIMITED
Boiler Technician
Indianapolis
FULL TIME & CONTRACT
November 19, 2024
View Job Description
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Delivery Tax Consultant II
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Tax Delivery Manager
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Associate Director - Assurance Data Analytics and Automation Strategy
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Looking for similar job?
Ameriprise India
Principal Lead - Salesforce CRM
Noida
FULL TIME
September 6, 2024
View Job Description
Ameriprise India
Principal Lead - SalesForce Marketing Cloud
Noida
FULL TIME
September 6, 2024
View Job Description
Bank of America
Principal Engineer - GBS IND - R
Hyderābād
FULL TIME
September 6, 2024
View Job Description
GLOBALFOUNDRIES
Principal Analyst Bus Unit Market Intelligence - Strategic Business role
FULL TIME
September 6, 2024
View Job Description
Cytel, India
Principal Statistical Programmer-Remote-FSP-Permanent
FULL TIME
September 8, 2024
View Job Description
See What’s New: Lilly Job Opportunities
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job DescriptionNew Job Alerts
Lilly
Sr. Director - Quality Transformation and Technology
Indianapolis
FULL TIME
November 19, 2024
View Job Description
ADIENTONE INDIA PRIVATE LIMITED
Boiler Technician
Indianapolis
FULL TIME & CONTRACT
November 19, 2024
View Job Description
Lilly
Quality Assurance Batch Disposition Representative
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Delivery Tax Consultant II
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Deloitte
Seasonal JSG Tax Delivery Manager
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Associate Director - Assurance Data Analytics and Automation Strategy
Indianapolis
FULL TIME
November 19, 2024
View Job Description
Lilly
Senior Director - LVA Digital Transformation
Indianapolis
FULL TIME
November 19, 2024
View Job Description