Senior Quality Systems Engineer, Quality Events
iRhythm TechnologiesSalary not specified
Full Time
Senior (5 to 8 years)
CDD - Représentant Assurance Qualité Opérations usine aseptique (F/H) at Eli Lilly and Company
Fegersheim, Grand Est, France
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutique, SantéIndustries
Requirements
- Pharmacien industriel thésé (ou en cours de validation), with ideally a Master in Assurance Qualité and/or Production Pharmaceutique and/or Ingénierie Pharmaceutique
- Première expérience professionnelle au plus proche des opérations de production de médicaments stériles (stage/alternance compris)
- Connaissance des standards Qualité en vigueur
- Capacité à convaincre et à influencer dans votre domaine d’expertise
- Capacité d’analyse et de synthèse
- Capacité à travailler en équipe et/ou en transverse et à adapter votre communication en fonction de vos interlocuteurs
- Bonne communication orale et écrite
- Capacité à établir des priorités et à gérer efficacement des problèmes variés et complexes
- Sens pédagogique
- Français: Langue maternelle ou niveau C1
- Anglais: Niveau B2 requis
Responsibilities
- Garantir l'application conforme des standards Qualité
- Proposer, décider, organiser et réaliser des actions Qualité dans votre domaine d’activité
- Approuver des éléments relevant de votre responsabilité
- Guider et coacher les autres fonctions sur les sujets Qualité
- Faire évoluer les processus et méthodes Qualité dans le cadre de l’amélioration continue
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for this position?
The remuneration starts from 42K € annual gross, depending on experience.
Is this a remote position or does it require being on-site?
The position is based at the Fegersheim site, 15 minutes from the center of Strasbourg, with occasional on-call or shift work.
What qualifications and skills are required for this role?
Candidates need to be a licensed industrial pharmacist (or in validation process), ideally with a Master's in Quality Assurance, Pharmaceutical Production, or Pharmaceutical Engineering, plus initial experience near sterile drug production operations including internships. Required skills include knowledge of quality standards, ability to convince and influence, analytical skills, teamwork, communication, prioritization, and pedagogical sense. French at native or C1 level and English at B2 level are required.
What is the team and work environment like at Eli Lilly's Fegersheim site?
You will work within the Quality Assurance team dedicated to aseptic production at the flagship Fegersheim site near Strasbourg, which has been innovative since 1967 and produces sterile injectable products for 21st-century health challenges like diabetes.
What makes a strong candidate for this Quality Assurance Representative role?
A strong candidate is a licensed industrial pharmacist with relevant Master's degrees, hands-on experience in sterile production operations, solid quality standards knowledge, influencing skills, teamwork abilities, and B2 English proficiency.
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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