Associate-QA Area at Eli Lilly and Company

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, HealthcareIndustries

Requirements

Bachelor degree or above, major in pharmaceuticals, chemistry or related sciences
At least three years of production or QA experience
Demonstrate strong oral and written communication and interpersonal skills
Demonstrate strong decision making and problem solving skills
Demonstrate knowledge and understanding of manufacturing process and quality systems
Demonstrate technical writing and communication skills
Capable of listening, speaking, reading and writing in English
Strong attention to detail (preferred)
Experience with SAP, PMX and TrackWise Deviation and Change Management processes (preferred)
Licensed pharmacist (preferred)

Responsibilities

Lead, mentor, and coach operations and support personnel on quality matters
Ensure regular presence in operational areas to monitor GMP programs and quality systems
As QA representative, be active in packaging local process team
Assess and triage deviations that occur within the local process team
Work with support teams and external partners to resolve or provide advice on product related issues (e.g., internal complaints, complaints investigation)
Participate in self-led inspections and provide support during internal/external regulatory inspections
Effectively review or approve documents to ensure quality attributes are met (e.g., deviations, procedures, technical studies, validation protocols, change controls and engineering documents)
Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization
As QA representative, support project and process improvement initiatives in the local process team
Be backup of shop floor QA, as necessary
Follow various HSE management procedures and fulfill work safety responsibilities

Skills

Key technologies and capabilities for this role

GMP ComplianceDeviation InvestigationChange ControlValidationBatch DispositionCommissioningQualificationQuality AssuranceMentoringCoachingPackaging OperationsAudits Preparation

Questions & Answers

Common questions about this position

What is the employment type for this Associate-QA Area position?

The position is full time.

Where is this Associate-QA Area role located?

The role is mainly related to Lilly Suzhou Pharmaceutical East Lake Packaging.

What key skills are required for the Associate-QA Area position?

Key skills include leading and coaching on quality matters, monitoring GMP programs, assessing deviations, reviewing documents like deviations and procedures, and participating in Six Sigma projects.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and seeks determined individuals who give their best effort.

What makes a strong candidate for this Associate-QA Area role?

Strong candidates should have experience in GMP compliance, leading quality investigations like deviations and change controls, participating in audits, and supporting process improvements in a pharmaceutical packaging environment.

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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