Quality Assurance Specialist

2 days ago

Cork, Cork, Ireland beBeeQuality Full time €80,000 - €100,000
Job Details

About the Role:

Eli Lilly Cork is a diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions in various Business Service functions.

We offer a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.

Our 'Live Your BEST Life' wellbeing initiatives enhance the career experience for our colleagues.

Key Responsibilities:

  • Recognize, exemplify and adhere to the Lilly values which center on our commitment to People, Excellence and Compliance.
  • Support the implementation, maintenance and operations of the Quality systems for the Global Business Solutions center.
  • Manage GMP compliance, GDP (Good Distribution Practice) and Product Complaint activities.

Key elements of the role include:
- Responsible to support the SOP system
- Support the product quality Personnel Qualification activities
- Manage and support the Deviation & Change Control system
- Support Recall activities ie. local at GBS and Affiliate

Compliance Activities:

  • Support compliance with any applicable Global Quality Standard & with the Quality Agreement in place between Global Business Solutions Cork/Medical Information & Affiliates.
  • Ensure that the regulatory and Quality impact review is done for deviations and Change Control.

Business Support:

  • Ensure the Global Business Solutions Center is following the appropriate Quality systems & specific requirements from Affiliates as part of the routine operations.
  • Ensure Quality coverage to the Supply Chain activities & interactions between Lilly Service Providers & Affiliates.

Requirements:

  • Degree in scientific disciplines such as Pharmacy, Chemistry, Biochemistry, Microbiology or other relevant Pharma experience positions.
  • 2 to 5 years experience within Quality Assurance, Supplier Quality, Regulatory, Medical Information, Laboratory, Supply Chain or other Quality related roles within Pharma.

Fluency in English, French, Dutch, and German is essential.
Proficient in MS Office, Good working knowledge in SAP, Trackwise and One QMS.

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