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Biotechnology Operations Specialist

3 weeks ago

Limerick, Limerick, Ireland Eli Lilly and Company Full time

We are a global healthcare leader headquartered in Indianapolis, Indiana.

Company Overview

We unite caring with discovery to make life better for people around the world. Our employees around the globe 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.

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. Our state-of-the-art manufacturing facility is at the forefront of innovation, employing the latest bioprocessing technologies to create life-saving therapies.

This position is based full-time on site in Raheen, Limerick.

Job Description
  • Technical Leadership:
    • Provide Quality leadership, direction, training and governance for the specific area of responsibility.
    • 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.
    • Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements.
    • Communication and education of personnel in GMP requirements and regulations.
  • Quality Monitoring Programs:
    • 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.
    • 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:
    • Responsible for approving appropriate quality-related documents. An approval signature confirms that Lilly, GMP and relevant regulatory requirements have been met.
    • 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.
    • 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.
    • 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.
    • Familiar with the contents of or else involved in the review/approval of the applicable Quality Agreements.
  • Regulatory Submission & RTQ Support:
    • Responsible for issuance of QP declarations where required.
    • Understand the conditions and requirements when a renewed authorisation is necessary and ensure they are complied with.
    • Evaluation and contribution of regulatory information to regulatory documents including review/approval of dossier sections as part of the product submission processes.
  • Batch Approval:
    • 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.
    • Ensure that biotech drug product batches are tested in compliance with manufacturing & marketing authorisations (BLA/MAAs/ROW CTDs).
    • Is responsible for the final decision associated with batch certification.
    • 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.