We're looking for individuals who are committed to enhancing the lives of people worldwide.
A career opportunity has arisen for a Production QA Senior Associate to support our expanding Small Molecule/Peptide Operations. This new role may involve implementing a shift pattern to support the Small Molecule Business. Lilly Kinsale operates under a Hybrid Working Policy.
Main Purpose and Objectives:
* Provide quality leadership, direction, and governance for specific areas of responsibility.
* Manage quality-related matters specific to areas of responsibility.
* Approve appropriate quality-related documents.
* Carry out day-to-day activities in compliance with site safety policies and procedures, promoting safe practices and reporting any safety concerns promptly.
* Perform ongoing monitoring, including:
o Monitoring of quality systems
o Production area time on floor audits
o Verification of effective implementation of key GMP programs
o Review of systems that impact product quality to ensure they operate in a state of control
* Provide QA ownership for areas of responsibility.
* Coach and mentor operations personnel and other QA reps on risk management to provide timely solutions to compliance in a business-focused manner.
* Review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies, and reports associated with manufactured batches.
* Review and approval of GMP documents related to 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, and disposition of raw materials, intermediates, and packaging components used in the manufacture of relevant pharmaceutical products when necessary.
* Batch disposition, including approval of batch records, for API and Intermediate batches, and approval of CoA's.
* Evaluation and contribution of regulatory information to regulatory documents.
* Monitoring of GMP compliance, GMP programs, and systems by ensuring regular presence in 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.
* Report and escalate critical quality issues to the appropriate level of quality management for final resolution.
* Experience working in cross-functional teams and proven ability in decision-making.
* Demonstrated ability in critical thinking, data analysis, problem-solving, and experience in root cause analysis.
* Strong organisational skills, including ability to follow assignments through to completion.
* Understanding of Data Integrity and its applications.
* Self-motivated, positive, and ability 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.
* Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set.
If you have a preference for shift positions, this can also be explored, which can be discussed further at the early stages of the interview process.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
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