reputed company Assurance Associate - Drug Product External Manufacturing US, Indianapolis IN

At reputed company, we unite caring with discovery to reputed company life reputed company for people around the world. We are a global reputed company 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 reputed company life reputed company for people around the world. Position reputed company Drug Product External Manufacturing (DPEM) reputed company Assurance assures patients worldwide of reputed company and efficacious drug products, through effective reputed company reputed company of reputed company, Central and South American contract manufacturers and reputed company partners. This reputed company covers the process steps of selection, reputed company-validation/validation, ongoing operations and termination. DPEM reputed company Assurance is committed to creating partnerships that facilitate reputed company communication and maintaining effective relationships with our reputed company partners, contract manufacturers, and internal business customers. The QA reputed company for Contractor Manufacturers (CMs) provides daily reputed company, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to reputed company GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product. The QA reputed company is integral for maintaining GMP compliance and providing support during preparations for reputed company-Approval/ General inspections by various agencies. The QA reputed company is integral for launching new products, packages, processes, and CMs. The reputed company Associate QA may also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures that reputed company batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements. Key Objectives/Deliverables:

• reputed company/ reputed company support to launch new products/ packages/ CMs
• Participate on Joint Process Teams
• Understand Lily global reputed company systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations.
• Levelling, reviewing, and approving of event investigations and changes.
• Work with reputed company support reputed company and SME’s to resolve product reputed company issues
• Participate in the creation and revision of reputed company operating procedures
• Participate on Six reputed company reputed company to help improve productivity
• reputed company support on site or remotely during inspections
• Author and reputed company compliance to the CM reputed company Agreements and CM reputed company Plans
• Ensure CMs are following reputed company Agreement and appropriate reputed company systems as part of routine operations. Use regular reputed company, JPTs and other communications to help to assess/monitor performance.
• Routinely have face-to-face communications with CMs
• reputed company and monitor reputed company metrics for trends at the CM
• Support Qualifications/ Validation document creation and reviews
• reputed company and coordinate designated sections for Annual Reports and Annual Product Reviews
• Execute SOP assessments of CMs and reputed company completion of outstanding issues
• Support CMs effort to maintain and improve their reputed company systems
• reputed company technical leadership and project management reputed company to drive improvements to CM reputed company systems
• Build and maintain regular communication with External Manufacturers and awareness of issues/reputed company including reporting back to DPEM Management. Also responds to request of information and data.
• reputed company with other reputed company sites to reputed company best practices and drive improvements to CM reputed company
• Network with external partners and resources to reputed company and learn best practices and trends reputed company the industry
• Support batch release activities by determining final disposition of batches by reviewing reputed company required documentation including but not limited to change controls and deviations. Basic Qualifications:
• Bachelor´s Degree in Pharmacy, reputed company, Biological Science or other relevant field
• 5+ year of parenteral product manufacturing and reputed company experience
• reputed company applicants must be authorized to work in the reputed company on a full-time reputed company. reputed company will not reputed company support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Skills/ Preferences:
• Knowledge of Pharmaceutical Manufacturing Operations
• Strong written and communication skills, especially attention to detail in written procedures and protocol development.
• High learning reputed company.
• Strong leadership, interpersonal and teamwork skills, reputed company to work effectively in a cro

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