Sr. Associate-quality Control
hace 9 meses
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.
- Quality oversight of Marketing Affiliate Operations (SPECC Region), supporting the execution of Quality System component on Quality Oversight of Affiliate Managed Laboratories performing importation testing.
- Ensure the Quality oversight of the Quality Control Laboratory activities; ensure compliance of the lab operations to corporate standards and local regulations; support the execution of the lab quality systems especially and not limited to deviations, analytical investigations, observations, operational procedures, specifications, analytical methods, OOS/OOT results, change control, maintenance of equipment and electronic systems, oversight of Alliance Partners and subcontracted labs etc.
- Management of external GMP/Laboratories that impact in Product Quality, including the establishment and revision of Quality Agreements; periodic review, support during internal and external audits.
- Reception of GMP audits, conduction of quality self-inspections in laboratories; quality assessment; management of action plans.
- Impact assessment of corporate standards and regulatory documents on quality processes for Affiliate GMP Laboratories.
- Partner with functional area data experts to anticipate and resolve key data management and integrity issues while driving solutions that impact the laboratories and align with corporate objectives.
- Veeva Quality Docs - Management of the local document control system (Veeva Quality Docs) for the Laboratory and Quality areas.
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.
WeAreLilly
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