Senior Associate QA API External Manufacturing Expert
6 days ago
We are seeking a highly skilled and experienced Senior Associate to join our team in the role of quality assurance for external manufacturing. The successful candidate will be responsible for ensuring all batches meet specifications, are manufactured in accordance with validated processes and compliant to cGMPs and regulatory commitments.
Responsibilities:- Serve as liaison between Contract Manufacturing Organizations (CMOs) and internal stakeholders.
- Provide quality oversight of CMOs including being the initial point of contact for all quality-related issues.
- Escalate quality issues at CMOs to management.
- Assist in establishment and revisions of Quality Agreements with affiliates and customers.
- Bachelor's degree in a science-related field such as Pharmacy, Chemistry or Biological Sciences.
- Five plus years of GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QA.
The ideal candidate will possess excellent communication and interpersonal skills, be able to organize and prioritize multiple tasks, and demonstrate strong attention to detail.
What We Offer:- A dynamic and collaborative work environment.
- Ongoing training and professional development opportunities.
- Competitive salary and benefits package.
In this role, you will have the opportunity to make a meaningful impact on the quality of our products and contribute to the success of our organization.
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Cork, Cork, Ireland Eli Lilly and Company Full timeAt 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...
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