Product Quality Representative

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Position Summary
The Quality Manager serves as both the Product Quality Representative (PQR) and the Qualified Person (QP) for the Israeli affiliate. This role is critical in ensuring compliance with Lilly Global Quality Standards, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and local regulatory requirements. The Quality Manager will lead the implementation of the affiliate's quality system, oversee batch release, and act as a key liaison with regulatory authorities and internal stakeholders.

Main Purpose And Objectives Of Position
As Product Quality Representative (PQR):

• Ensure the implementation and execution of Lilly Global Quality Standards at the affiliate.
• Ensure the implementation and execution of an adequate product quality system based on Lilly Quality Standards and applicable local regulations.
• Collaborate with the Regional Quality Team to seek advice, inputs and guidance in all related quality matters/projects.

As Qualified Person (QP)

• Ensure compliance with Pharmacists Regulations (GMP for Products) 2010.
• Certify that each batch released for marketing complies with the product registration and regulatory requirements.
• Assist to global quality leader regarding policies, processes and procedures.

Scope:
Israel

Educational Requirements

• Knowledge of local procedures and Global Quality Standards relating to product quality system and batch release, other procedures related to the roles and responsibilities, and successful completion of the related knowledge assessments, if any.
• The QP shall be a qualified pharmacist of at least two years' proven experience in an authorized business, in the activities of qualitative and quantitative analysis of active substances and medicinal products and of the testing and checking necessary to ensure the quality of medicinal products.

As part of the QP qualification, the QP is expected to visit the drug products manufacturing site.

Educational & Professional Requirements

• Pharmacy degree with a valid Pharmacist License in Israel.
• Completion of a Qualified Person (QP) certification course.
• Willingness to visit manufacturing sites as part of QP responsibilities.

Soft Skills

• Decision-making capabilities in a regulated environment.
• Strong interpersonal and communication skills, with the ability to influence cross-functional teams.
• High level of accountability, integrity, and attention to detail.
• Ability to prioritize, manage complexity, and adapt in a dynamic environment.
• Proven ability to lead through change, foster collaboration, and drive continuous improvement.

Language Requirements

• Fluent in Hebrew (spoken and written).
• Fluent in English (spoken and written).

Key Responsibilities
Legal Responsibility for the Qualified Person (QP):

About
The Responsible Pharmacist should accomplish the local regulations about the Responsible Pharmacist (Qualified Person) functions and product release. The chief duties of a responsible pharmacist are listed in the Pharmacists Regulations (GMP for Products) 2010:

• To ensure that each batch of medicinal product released for marketing shall have been manufactured and tested in accordance with the terms set out in the Medicinal Products Ordinance and Regulations and in conformity with the product's terms of registration.
• To certify in a register batch release documents and keep them in a special place under its responsibility; to keep the register up to date for a period of at least five years; the responsible pharmacist shall have the register available for the Director's inspection at any time.
• The responsible pharmacist of an authorized business shall certify that every batch of medicinal product imported into Israel only after the batch has undergone a full qualitative analysis, in accordance with the requirements of the marketing authorization.

Routine Duties

• To give notice to the Ministry of Health (MoH) in respect of every batch that is approved for marketing, after verified and tested the batch pursuant to the guidelines given in the clarification paper. Notice of release shall also be sent for a repeated batch.
• Assure GMP records are properly maintained at the affiliate.
• Ensure the validity of importation permits.
• To evaluate and respond to pharmacies and consumers include inquiries concerning temperature excursions.

For Product Quality Representative (PQR)
Implementation of the Product Quality System at the affiliate, covering but not limited to: Procedures system, Quality Manual and related activities, Training, Documentation and Data, Complaint system, Deviation system, Returned products management, Change Control system, Notification to Management system, Corrective and Preventive Actions (CAPA), Quality Plan, Quality systems trending, Recalls management, Product Complaints management, Regulatory compliance, GMP/Product Quality decisions in conjunction with Regional Quality Team, Physician Samples and Promotional Materials with GMP impact, Product Customization, Product Counterfeit Protection, Audit readiness & follow-up on audit finding and health authority inspection. Involvement in projects linked to Quality Systems at the affiliate such as: Product Receipt, Warehouse Management and Distribution management, customization initiatives and External Parties for GMP activities.

Other Responsibilities

• Act as back-up for the affiliate Responsible Complaint Person (RCP).
• Perform as the affiliate Regulatory, Quality, Pharmacovigilance Department and MSLs Record Information Management (RIM) Steward for the and assure implementation of the Global RIM program.
• Perform as the Recall Coordinate - responsible to coordinate recall information to Regional Quality Leader/Affiliate team/Israeli MoH.

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