Senior Associate - QA for Quality Control

Kinsale, County Cork, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Quality ControlIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific discipline, such as Chemistry, Biology, or a related field, and have at least 3 years of experience in Quality Control within a pharmaceutical or biopharmaceutical manufacturing environment. A strong understanding of cGMP regulations and quality systems is essential, along with experience in laboratory analytical methods and data interpretation.

Responsibilities

The Sr. Associate - QA for Quality Control Labs will provide Quality leadership, direction, and governance for their specific area of responsibility, manage quality-related matters, approve quality-related documents, monitor quality systems, oversee the self-inspection program, verify GMP program implementation, review systems impacting product and data quality, establish and manage control systems, and train personnel. Additionally, the role involves maintaining GMP compliance, establishing and managing control systems, ensuring the Quality System remains validated, interpreting regulatory guidelines, benchmarking initiatives, assessing impact on product quality, reviewing and approving investigations and change controls, and reporting critical quality issues.

Skills

GMP

Quality Systems

Regulatory Guidelines

Quality System

Self-inspection

Verification

cGMP

Data Quality

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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