Senior Associate - QA Small Molecule/Peptides for Materials Management

at  Lilly

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.
There is an opening for production QA Senior Associate to support our growing Small Molecule/Peptide Operations. This new role maybe developed to introduce a shift pattern to support the Small Molecule Business. Lilly Kinsale has a Hybrid Working Policy.

EDUCATIONAL REQUIREMENTS

• Hons BSc, MSc, or PhD in Chemistry, Engineering or related discipline, with a minimum of 2 years specific relevant experience in a production role.

MAIN PURPOSE AND OBJECTIVES OF POSITION:

• Provide Quality leadership, direction and governance for the specific areas of responsibility.
• Manage quality-related matters specific to area of responsibility.
• Responsible for approving appropriate quality-related documents.
• Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices & promptly report any safety concerns.
• Perform ongoing monitoring that includes: Monitoring of quality systems, production area time on floor audits, verification of the effective implementation of key GMP programs and review of systems that impact product quality to ensure that they operate in a state of control.
• Provide QA ownership for area of responsibility.
• Provide coaching and mentoring to operations personnel and to other QA reps on appropriate risk management to provide appropriate and timely solutions to compliance in a business focused fashion.

KEY RESPONSIBILITIES:

• Review and approval of key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas
• Review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
• Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
• Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
• Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA’s.
• Evaluation and contribution of regulatory information to regulatory documents
• Monitoring of GMP compliance, GMP programs and systems by ensuring a regular presence the area of responsibility
• Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
• Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.