We're looking for people who are determined to make life better for people around the world.
Senior Associate, QA Role
Support online manufacturing at Lilly Kinsale as a Senior Associate, Quality Assurance.
Main Purpose and Objectives
* Provide quality leadership, direction, and governance in specific areas of responsibility.
* Manage quality-related matters specific to the area of responsibility.
* Approve quality-related documents as necessary.
* Ensure day-to-day activities comply with site safety policies and procedures.
* Promote safe practices and report any safety concerns promptly.
* Monitor quality systems, production areas, and GMP programs to ensure they operate effectively.
* Take ownership of product quality for manufactured products.
* Coach and mentor operations personnel on risk management and compliance.
Key Responsibilities
* Review and approve GMP standard operating procedures, raw material specifications, sampling protocols, and master formulas.
* Review and approval of qualification and validation documents, including IQ/OQ/PQ and validation documents.
* Re-identify, re-evaluate, and dispose of raw materials and packaging components as necessary.
* Evaluate regulatory information and contribute to regulatory documents.
* Monitor GMP compliance, data integrity, and systems in the area of responsibility.
* Participate in site self-inspections and audits to ensure compliance with product quality systems.
* Report and escalate critical quality issues to quality management.
Requirements
* Hons BSc, MSc, or PhD in Pharmacy, Chemistry, Engineering, Quality, or related discipline.
* Minimum 2 years relevant experience.
Key Attributes
* Excellent attention to detail.
* Experience working in cross-functional teams and proven decision-making ability.
* Critical thinking, data analysis, problem-solving, and root cause analysis skills.
* Strong organizational skills and ability to follow assignments through to completion.
* Understanding of Data Integrity and its applications.
* Self-motivated, positive, and able to work under pressure.
* Demonstrates flexibility and adaptability to meet business needs.
* Excellent interpersonal and communication skills (written and oral).
* Demonstrates a continuous improvement mind-set.
Lilly's Commitment to Diversity and Inclusion
Lilly does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.