At Lilly, We Unite Caring with Discovery
We are a global healthcare leader headquartered in Indianapolis, Indiana.
Our Mission:
* To discover and bring life-changing medicines to those who need them.
* To improve the understanding and management of disease.
* To give back to our communities through philanthropy and volunteerism.
About Eli Lilly Limerick
Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry.
Position Summary:
The Qualified Person (QP) plays a pivotal role in ensuring the quality and regulatory compliance of our biopharmaceutical products.
Key Responsibilities:
* Technical Leadership:
o Provide Quality leadership, direction, training and governance for the specific area of responsibility.
o Carry out day to day activities in compliance with site safety policy and procedure.
o Maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements.
o Communication and education of personnel in GMP requirements and regulations.
* Quality Monitoring Programs:
o Monitoring of GMP compliance and verification of the effective implementation of key GMP programs and systems.
o Monitoring of the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
* Document Review/Approval:
o Responsible for approving appropriate quality-related documents.
o Review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
o Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic review reports (PRR) and annual product reviews (APR) product quality evaluations.
* Regulatory Submission & RTQ Support:
o Responsible for issuance of QP declarations where required.
o Understand the conditions and requirements when a renewed authorisation is necessary and ensure they are complied with.
o Evaluation and contribution of regulatory information to regulatory documents including review/approval of dossier sections as part of the product submission processes.
* Batch Approval:
o Ensures manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation.
o Ensure that biotech drug product batches are tested in compliance with manufacturing & marketing authorisations (BLA/MAAs/ROW CTDs).
o Is responsible for the final decision associated with batch certification.
Basic Qualifications:
* BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or related discipline.
* Must be approved by member state as a licensed QP in order to be named on the company licence as a QP.
Additional Skills/Experience:
* Minimum of 10 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
* Strong understanding and working knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
* Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.
What We Offer:
A competitive salary and benefits package.
Opportunities for professional growth and development.