Associate Director-Qa Pfs
3 giorni fa
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.
**BROAD FUNCTION**:
- Responsible of providing the Quality oversight and coordination of quality activities/areas regarding PFS area ( Formulation, Filling, Visual Inspection) according to the cGMP's and Eli Lilly standards
- Ensures inspection readiness of the area and inspection management.
- Responsible for batch review and disposition of semifinished products
**MAIN RESPONSIBILITIES**:
- Guarantees Q oversight of the activities related to PFS line including EM, MI&CS, FUME and batch release of dulaglutide semifinished products.
- Responsible rf batch review and disposition of semifinished products for Sesto site
- Ensure collaboration with the GMP compliance team for self inspection and external audits activities. Influence on key initiatives sharing, networking on trends and initiatives.
- Partecipates to Quality Lead Team, and to Science Lead Team if necessary.
- Coordinates and has oversight on all activities of the PFS Quality resources.
- Develops technical knowledge and soft skills of her/his direct reports providing feedback, support, oversight and training.
- May perform Batch Review and Disposition of dulaglutide semifinished batches.
- Approves change controls, procedures, production procedures and CHG for PFS line.
- Ensures the notification of safety issues of the dept and guarantee the compliance with H&S procedures.
- Cooperation in site Quality Systems and Quality Culture initiatives.
- Ensure adequate escalation to management.
- Partecipates to self inspection program
- Ensures inspection readiness of the area and participates to regulatory inspections
**RELATIONSHIPS**:
- All site functions, Parenteral Network, Global Quality Unit; other Lilly Manufacturinq sites, Parenteral Global Program
**REQUIRED QUALIFICATIONS**:
- Pharmacy degree or Master's degree in chemistry, physical or biological sciences or Engineering degree.
- Fluent English - Italian
- At least 5 years of pharmaceutical industry experience operations. Good knowledge of current GM P's and Lilly 's Quality Systems.
- Good knowledge of pharmaceutical legislation and regulatory requirements.
- Knowledge of sterile and packaging manufacturing processes.
- Good prioritization skills and ability to determine the criticality of quality issues
- Good communication and interpersonal skills, influencing skills and good team working/ partnership skills to working a cross-functional organization.
- Pragmatic approach and compliance mindset
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.
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