Product Quality Representative Benelux
Il y a 2 mois
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.
**Purpose of the position**
As the Product Quality Representative (PQR) for Belgium/Luxemburg and The Netherlands (BENELUX):
- Be the contact for the Marketing Affiliates organization about the product quality and provide quality oversight for Eli Lilly products and medical devices distributed within BENELUX through the affiliate quality system via:
- Implementation and maintenance of an affiliate product quality system as required by Global Quality Standard GQS 181 Marketing Affiliate Operations and the Common Quality Practice CQP 181-1 Product Quality Operational Manual and local regulatory requirements.
As the Marketing Authorization Holder (MAH) Quality Representative for Belgium/Luxemburg:
- Ensure that the requirements of the EMA concept paper on Good Manufacturing Practice and Marketing Authorization Holders are implemented
As the Recall Coordinator for BENELUX:
- Ensure the execution and coordination of recalls/product defects of Eli Lilly products (including medical devices and promotional materials with Quality impact) as required and in conjunction with Responsible persons.
**Key elements of the Role - Essential Functions**
As the Product Quality Representative (PQR):
- Coordinate and manage all product quality related matters and advise, decide, and report on all quality issues within the affiliate. Promptly escalate and consult as needed to the regional quality leader, the Responsible Persons as needed and/or to the broader organization via notification to management for final resolution.
- Ensure that a Product Quality Management System is implemented but not limited to:
- Local Product Quality Manual and SOP reflecting local regulations and Lilly requirements
- Deviation system to manage Product Quality issues (ensuring they are investigated, documented with appropriate CAPAs)
- Change Control system
- Notification to Management system
- Monitoring and trending of quality systems
- Affiliate Quality plan
- Self-Inspection
- Product Complaint system
- Keep appropriate records of any delegated duties.
- Ensure that service providers that handle or distribute products meet quality expectations as per local and Lilly requirements, and where applicable, local controlled drug and Lilly-designated Special Security Substance expectations.
- Ensure that suppliers and customers are approved.
- Decide on the final disposition of returned, rejected, recalled, or falsified products in conjunction with the Responsible Persons and as per CQP 181 - 1 requirement.
- Ensure that a system is in place to manage physician-sampling programs according to product quality, and where applicable, local controlled drug and Lilly-designated Special Security Substance requirements.
- Ensure that a process to manage serialization alerts, reports of suspect or tampered our counterfeited products from product complaints, adverse events, or returned product is in place as per local regulations and Lilly standard.
- Ensure acceptability of promotional items that have the potential to directly impact the product quality or patient safety,
- Work with the regional quality leader to assure suitable area(s) and process(s), are used for any additional operations to be carried out on finished product prior to distribution (product customization: e.g., addition of stickers, stamping, special packaging for refrigerated items).
- Ensure in conjunction with Responsible Persons appropriate communication with Regulatory Authorities about product quality matters and MAH responsibilities, including product shortages, counterfeit and quality defects
- Ensure that any agreement into which the marketing affiliate enters receives appropriate quality oversight according to LQS102 - Quality Management of Collaborations with External Parties
- Ensure monitoring for local regulations to ensure appropriate implementation of any local or European laws/guidance with potential product quality impact.
- Provide support to any project with Product Quality impact at affiliate level
As the Marketing Authorization Holder (MAH) Quality Representative:
- Work in close contact with the person responsible of the preparation of the APR (Annual Product Review) and approve APR for all products for which Lilly Belgium/Luxemburg is the MAH.
As the Recall Coordinator:
- Coordinate and promptly execute in conjunction with Responsible Persons any recall or mock recall operations for medicinal products, devices a
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