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About Us
Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals.
Position Summary
The Qualified Person plays a pivotal role in ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility.
Key Responsibilities:
1. 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. Promote and encourage safe practices and promptly report any safety concerns.
o Continue to 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.
2. Quality Monitoring Programs
o Monitoring of GMP compliance and verification of the effective implementation of key GMP programs and systems by ensuring a regular presence in the area of responsibility.
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.
3. Document Review/Approval
o Responsible for approving appropriate quality-related documents. An approval signature confirms that Lilly, GMP and relevant regulatory requirements have been met.
o As per the requirements of local procedures, 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 As per the requirements of local procedures, 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.
o As per the requirements of local procedures, review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
o Familiar with the contents of or else involved in the review/approval of the applicable Quality Agreements.
4. 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.
5. 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.
o Ensures that the principles and guidelines of GMP as stated in 2003/94EC, 2001/83EC, 536/2014 (repealing 2001/20/EC), associated EU GMP annexes, (e.g., Annex 13, Annex 16) and current product specification file (PSF) are met.
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.
* Demonstrated success in influencing without authority.
* Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.
* Ability to communicate effectively with all levels and functions in the organisation.
* Ability to work on multiple concurrent project initiatives.
* Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.