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Eli Lilly and Company
Eli Lilly and Company
BiotehnologijaFarmacevtski izdelkiZdravstveno varstvo
Eli Lilly and Company je večnacionalno farmacevtsko in zdravstveno podjetje, osredotočeno na odkrivanje, razvoj, proizvodnjo in trženje zdravil na recept. Njegovo delovanje zajema terapevtska področja, kot so sladkorna bolezen, onkologija, imunologija, nevroznanost in obvladovanje bolečine, pri čemer povezuje raziskave in razvoj s kliničnimi preskušanji, regulativnimi postopki, proizvodnjo bioloških zdravil in zdravil z majhnimi molekulami ter globalno distribucijo.
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Delovna mesta v podjetju

Principal Associate Quality Auditor, GCP

Conduct GCP audits across Lilly’s global pharmaceutical operations, assessing regulatory compliance and supporting risk-based quality oversight of internal and external operations.

SGSingapurNa daljavoPolni delovni časSrednja ravenZahtevani Jezik: angleščinaRevizor
Google Cloud Platform

Opis

  • Plan and deliver audits of internal and external GCP operations, from preparation through reporting.
  • Evaluate compliance with company standards, procedures, regulations, and guidance.
  • Help assess GCP operational risks for the annual risk-based audit plan.
  • Escalate compliance concerns through appropriate channels.
  • Keep current with relevant regulations, technical requirements, and training standards.
  • Help develop and review quality standards, policies, procedures, and guidance.
  • Compile organizational metrics and identify trends in audit findings.
  • Guide GCP teams on applying corporate and regulatory quality management requirements.
  • Complete required training and track industry developments and regulatory interpretations.
  • Share GCP expertise and support auditor training and qualification.
  • Contribute to divisional improvement work, including Six Sigma projects and departmental teams.
  • Build productive working relationships with internal and external stakeholders.

Zahteve

  • Bachelor’s degree or equivalent experience in physical or biological sciences or another relevant technical field.
  • At least five years of relevant GCP experience at Lilly or in the pharmaceutical industry.
  • Experience working with third-party organizations.
  • Ability to understand detailed scientific information while maintaining a broad perspective.
  • Ability to interpret and apply regulations, regulatory guidance, codes, public expectations, and compliance changes.
  • Strong interpersonal skills and the ability to stay constructive and civil in challenging situations.
  • Ability to communicate clearly, accurately, and promptly, in writing and orally, with people at all organizational levels.
  • Experience working on a global team and sharing knowledge.
  • Computer skills, including entering information in databases.
  • Sound analytical and problem-solving abilities.
  • Strong spoken and written English skills.
  • Willingness and ability to travel domestically and internationally up to 40%, including trips of one to two weeks and occasional short-notice travel.
  • Japanese business communication skills, spoken and written, are an advantage.
  • Ability to handle multiple tasks and deadlines in a fast-paced setting.
  • Process awareness and project management skills.
  • Ability to work independently and collaboratively with a global team.
  • Ability to give constructive feedback to customers and manage change or conflict.

Ugodnosti

  • Disability accommodation is available during the application process.
  • The company states its commitment to equal opportunity and nondiscrimination.
  • Professional development opportunities include training courses, conferences, and association meetings.
  • Role-specific training is provided through an Individual Training Plan (ITP).
  • The role offers opportunities to contribute to Six Sigma projects and departmental improvement teams.

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