Product Quality Representative (PQR) and Responsible Pharmacist for Batch Release (Qualified Person) at Eli Lilly and Company

Ra'anana, M, Israel

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Pharmacy degree with a valid Pharmacist License in Israel
Completion of a Qualified Person (QP) certification course
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
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
Willingness to visit manufacturing sites as part of QP responsibilities
Fluent in Hebrew (spoken and written)
Fluent in English (spoken and written)
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

Responsibilities

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
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 global quality leader regarding policies, processes, and procedures
Accomplish local regulations about the Responsible Pharmacist (Qualified Person) functions and product release
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
Certify in a register batch release documents and keep them in a special place under its responsibility; keep the register up to date
Lead the implementation of the affiliate’s quality system
Oversee batch release
Act as a key liaison with regulatory authorities and internal stakeholders

Skills

GMP

GDP

Batch Release

Quality Management

Regulatory Compliance

Qualified Person

Product Quality System

Lilly Global Quality Standards

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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