Quality Assurance Associate at Eli Lilly and Company

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Recognize, exemplify and adhere to the Lilly values (commitment to People, Excellence and Compliance)
Ability to collaborate with Affiliates, Business Operations Medical Information and Order to Cash, Regional Quality and Quality Assurance Associate Director for the GBS’s
Support and manage GMP compliance, GDP (Good Distribution Practice) and Product Complaint activities, and GMP decisions on Products and Quality issues in conjunction with the appropriate Affiliate Product Quality Representative, Regional Quality Leader and GBS QA Associate Director
Serve as Product Quality instructor/trainer for personnel (GMP Induction and GMP refresher)

Responsibilities

Support the implementation, maintenance and operations of the Quality systems for the Global Business Solutions center
Support the SOP system (from initiation to review and approval)
Support the GMP record retention system
Support the product quality Personnel Qualification activities
Support the Deviation & Change Control system (inclusive of evaluations, close out, tracking and trending)
Manage and support the Quality Plan (propose actions and action owner)
Support the Quality Manual
Support Recall activities (local at GBS and Affiliate)
Support Product Complaints management process from receipt and entry into the database system up to responding to the complainant and final close out, while keeping the local Responsible Complaint Person (RCP) and Product Quality Representative (PQR) involved in communications
Support projects with Quality involvement
Support compliance with any applicable Global Quality Standard & with the Quality Agreement in place

Skills

Key technologies and capabilities for this role

Quality Assurance

Questions & Answers

Common questions about this position

What benefits does Eli Lilly Cork offer?

Eli Lilly Cork offers flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, on-site parking, Inhouse People Development services, Educational Assistance, and ‘Live Your BEST Life’ wellbeing initiatives.

Is this a remote or hybrid role?

The role offers flexible hybrid working options from the campus in Little Island.

What are the key responsibilities of the Quality Assurance Associate?

The role involves supporting the implementation, maintenance and operations of Quality systems for the Global Business Solutions center, managing GMP compliance, GDP and Product Complaint activities, and making GMP decisions on Products and Quality issues.

What is the company culture like at Eli Lilly Cork?

Eli Lilly Cork features a talented diverse team of over 2000 employees across 60 nationalities, with a strong commitment to diversity, equity and inclusion (DEI) through pillars like EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network, and encourages employees to Be Creative, Be an Innovator, and Be Yourself.

What does Eli Lilly value in its employees?

Eli Lilly values adherence to its core commitments of People, Excellence and Compliance, and seeks determined individuals who put people first and work to make life better.

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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