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Ensure compliance with local Good Clinical Practice (GCP) Quality System as well as compliance with applicable Türkiye MOH regulations.
Technical training, personal skills and experience required:
A university degree in Pharmacy from Türkiye.
Minimum 2 years’ experience in quality assurance applied to the pharmaceutical industry.
Working knowledge of GCP regulations and quality system implementation and the ability to interpret and apply them for Quality Assurance (QA) responsibilities
Fluent in English (conversational, writing and reading) Knowledge and mastery of basic computing tools (Microsoft office).
Good interpersonal relations Ability to train working groups.
Good analytical skills and attention to details.
High initiative, learning agility and a flexible, positive attitude.
High degree of accuracy and attentive to details.
The Responsible Manager Delegate for Clinical Trial Materials is responsible for:
Act as delegated Responsible Manager to Perform Quality checks for the release of the Clinical Trial Products upon arrival to Türkiye.
Release clinical trial product shipments that meet all quality specifications and local regulations as a delegated Responsible Manager.
Support inspection readiness activities for MOH inspections. Assure that deviations, change management processes, root cause investigations, and corrective/preventive actions are effectively managed, documented, escalated, and completed in a timely manner.
Monitor compliance with the external party which is responsible for storage and distribution of Clinical Trial Materials.
Assist on training programs to external vendors which might have impact on Clinical Trial Material operations.
Review the returned products, ensure that any potential quality issue or failure that could have originated the return will be reported appropriately and coordinate if new provision applies to these products Support Quality Manager on reviewing/ updating Quality Agreements related to Clinical Trial Products Act as a point of contact for quality release of clinical trial materials in Türkiye affiliate.
Provide appropriate escalation of issues clinical teams and affiliate Responsible Manager.
Understand performance metrics related to CT material and identify areas for improvement and simplification.
Understand SOPs and processes for CT materials.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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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