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DPEM QA for QC representative provides assistance, to Contract Manufacturers (CMs), including external laboratories and other DPEM members for lab activities. QA for QC representative is responsible for improving technical capabilities, supporting operational control strategy, resolution of the most analytical deviations and supporting analytical projects.

This role provides guidance to primary loop with respect to daily CM laboratory activities and support 2ry loop s in method transfers and method/process validations to ensure that laboratory activities conducted by CMs and external laboratories are executed in accordance with company quality policies and procedures and comply with current Good Manufacturing Practice (cGMP) guidelines and regulations.

Key Objectives/Deliverables:

Support the oversight of Laboratory and Stability Quality System and operations:

QA representative with experience in Laboratory system quality elements. Provide feedback and coaching, to the personnel on the interpretation of corporate and regulatory GMP requirements (GQS) related to laboratory topics.

Support the DPEM laboratory technical capabilities by helping primary loop QA representatives on laboratory and stability topics.

Through liaison with DPEM Quality Management and 2ry loop laboratory role, monitor the performance at contract manufacturers/external laboratories and identify concerns as relevant. Escalate concerns in a timely manner with recommendations.

Provide support for onsite and remote Inspections/Audits (observation and answers), before during and after inspection

Provide support on training in relation with Laboratory topics within DPEM and CMs upon request.

Develop internal network contacts for supporting investigations, keeping aware of emerging topics in Lilly and understanding the impact on Contract Manufacturing and External Laboratory activities.

Participate in the creation and review of local procedures related to laboratory quality activities.

Support the review of new and revised standards (GQS and CQPs) related to laboratory series GQS600, LQP-101-6 and Stability GQS109.

Support related assessments and determine impact on DPEM processes and procedures. Work with DPEM management, 2ry lab loop role and Quality Systems owners to develop and create appropriate action plan to ensure alignment with required standards.

Support the review, maintain and improve DPEM Standard Operating Procedures (SOPs) related to laboratory (Reference standards, Pharmacopeia changes, Analytical investigations, and Laboratory accreditation) and Stability (Stability management).

Help on the preparation of GQS600 review at least once a year in accordance to GQS 101 including global standards changes and assessment.

Support the track and monitor laboratory metrics for trend for CMs/products included in the same platform

Support stability assessments including global standard changes and help preparing stability data periodic updates.

Contract Manufacturing support (as required):

Provide guidance and support for deviations, change controls, CAPA identification, technical report writing, as needed.

Create/Review/approve analytical deviations and change controls, technical reports, and any other analytical document, as needed.

Support laboratory evaluations. Help with the annual laboratory evaluation plan to ensure compliance to laboratory evaluation schedule across CM and follow up of identified actions status.

Provide oversight to DPEM stability program, including protocols, studies, metrics and routine overview of data and metrics.

Help with the assessment of capabilities of existing CMs to produce additional products, particularly with regards to laboratory topics.

Provide support to the assessment of new laboratories/implementation of new products/ CM.

Provide support to analytical transfer activities. Review method transfer/validation protocols, reports and methods as required.

Support on bellow laboratory activities:

Global method changes impacting external manufacturing: Coordination with related QA contact of the impacted CM to confirm impact assessment, global method and change approval where applicable and local implementation oversight.

Global compendia changes, pharmacopeia notifications and updates. Evaluation of global compendia reports, impact assessment and notification management to the QA reps for impacted CMs.

Reference standards profiles changes: Management of global notifications for profiles publications, link with CRSO for profiles delays or cancelation.

Data integrity topics and initiatives related to the laboratory.

Provide method transfer certification support (New products, method changes requiring certification)

Support communications between QA Leads/ CMs and global GQS SMEs relating to laboratory and stability standards.

Provide support to the laboratory performance review and Stability program monitoring in scope of JPT dashboards, huddle boards, IOPs and Steering meetings reviews.

Continuous Improvement:

Support projects management to drive improvement to DPEM and CM Laboratory Quality system.

Support CMs/Contract Laboratory efforts to maintain and improve their quality systems, including consulting with CM laboratories to understand Lilly laboratory quality requirements.

Participate on Lean initiatives to help improve productivity.

Basic Qualifications

Education:

Experience:

Skills:

Knowledge of laboratory quality system, method, and equipment.

Technical understanding of GMPs and the Global Quality Standards.

A thorough understanding of cGMPs and Global Quality Standards.

Strong written and communication skills, especially attention to detail.

Interpersonal and teamwork skills, able to work effectively in a cross functional team environment.

Ability to organize, prioritize, multi-task and influence others.

Decision making and problem-solving skills.

Willingness to learn new technologies.

Capability to work in a virtual and complex environment.

Willingness to travel.

Appreciation for cultural diversity.

Additional Skills/ Preferences

Established technical, quality, and internal networks.

Experience with systems (Darwin/LIMs, SAP, Trackwise, QDocs…etc).

Previous experience supporting manufacturing operations.

Understanding of micro/sterility testing.

Additional Information

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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