Associate - QA for Qc Dpem

1 mese fa

Sesto Fiorentino, Italia Lilly A tempo pieno

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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.
- Ref

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