GMP Quality Representative
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 39,000 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.
Qualification and Maintenance of the GMP Pharmacy
• Be the quality expert in the qualification of the GMP Pharmacy.
• Ensure the maintenance of the GMP pharmacy is in accordance to local regulations and requirements.
• Oversee quality aspects of activities related to the qualification and maintenance of the GMP pharmacy, which can include Commissioning and Qualification of GMP assets and review and approval of associated documentation.
Managing the Pharmacy Quality Management Systems
• Accountable for the creation and effective implementation of quality management in the GMP pharmacy.
• Ensure local implementation of global policies and procedures in business practices in the GMP pharmacy.
• Oversee service providers and vendors and ensure appropriate agreements (e.g.: Quality Agreements) are in place.
• Have quality oversight of the GMP pharmacy activities, which may include:
- Facility, Utilities, HVAC, and Equipment (FUME) to ensure compliance with quality systems.
- Maintenance/Calibration programs, including review and approval of work performed by GMP Service Providers.
- Contamination Control strategy, including the Environmental Monitoring and Cleaning programs.
• Create and maintain the Pharmacy Quality Manual and ensure compliance to requirements of the Quality Manual.
• Ensure implementation of appropriate change control systems and deviation/non-compliance reporting.
• Escalate/Notification to Management for departure of critical nature and assure issues are addressed appropriately.
• Identify opportunities for and participate in continuous improvement.
Inspections and Audits
• Hosts and facilitates inspections and audits for the GMP Pharmacy.
• Lead in inspection and audit preparation activities.
• Coordinate responses to inspections and audits.
• Ensures that appropriate CAPA is put in place for inspections/audits and tracks completion of commitments.
• Conduct shared learning sessions from inspections/audits.
• Perform internal qualify self-assessments and inspections.
• Ensure activities in the GMP pharmacy are in compliance to local regulations and cGMP requirements.
• Participate in other work related activities, according to supervisor’s instruction.
• Ensures compliance to individual training requirements and global policies.
REQUIRED QUALIFICATIONS AND EXPERIENCE
• Bachelor’s or Master’s Degree in a science or health care related field, or engineering.
• Five years experience working in a GMP environment.
• At least 3 years experience working as a Quality person in a GMP environment.
• Knowledgeable of cGMP regulations and GMP Quality Systems.
• Able to communicate effectively, both written and verbal and to influence others.
• Able to prioritize and handle multiple concurrent task.
• Able to apply risk-based decision making in a regulated environment and apply phase-appropriate GMP standards.
• Able to work independently when required.
• Occasional Travel to US may be required (less than 10%) for training, conferences, etc.
• Able to attend/participate/lead meetings (via teleconferences) after official office hours.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-8149.
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.
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