We are seeking a dedicated individual to contribute to improving the lives of people worldwide.
Senior Associate - QA Small Molecule Operations
This position involves providing quality leadership and direction in Small Molecule Operations, with opportunities for flexible working arrangements under Lilly's Hybrid Working Policy.
Main Responsibilities:
* Provide strategic guidance on quality matters and ensure compliance with site safety policies and procedures.
* Manage quality-related issues and approve relevant documents.
* Conduct regular audits and verify effective implementation of key GMP programs.
* Ensure quality ownership for products manufactured within the area of responsibility.
* Coach and mentor operations personnel on risk management and compliance.
Key Tasks:
* Review and approve GMP documents, including standard operating procedures and raw material specifications.
* Evaluate change controls, observations, and deviations related to product quality.
* Approve qualification and validation documents, including IQ/OQ/PQ and validation records.
* Dispose of raw materials and packaging components as necessary.
* Batch disposition, including approval of batch records and certificates of analysis.
* Monitor GMP compliance and participate in site self-inspections.
* Report and escalate critical quality issues to senior management.
Requirements:
* Bachelor's or Master's degree in Chemistry, Engineering, or a related field, with at least 2 years of relevant experience in production.
* Excellent attention to detail, decision-making skills, and ability to work in cross-functional teams.
* Critical thinking, data analysis, problem-solving, and root cause analysis skills.
* Strong organizational and time management skills, with the ability to follow assignments through to completion.
* Understanding of Data Integrity principles and applications.
* Self-motivation, adaptability, and excellent interpersonal and communication skills.
About Us:
Lilly is an equal opportunities employer and welcomes applications from diverse candidates. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, or any other protected status.