Senior Associate II, Supplier Quality

Pharmaceutical Ops & Technology

Description

Broad Function

  • Assist in the management of the day to day Quality Agreement activities associated with the Partner site(s), including manufacturing, warehousing and analytical testing
  • Assist in the Quality oversight of the validation activities at the Hillerod ILS facilty

Key Deliverables

  • Assist under the direction of the Senior Manager Product Quality Management the oversight of the development, maintenance and management of the Quality Agreements with partners
  • Review Master Batch Record generated at the partner sites for Biogen Idec products
  • Review validation documentation and additional testing protocols
  • Develop and maintain data analysis trending systems
  • Manage the Technical Product Complaints interface with partners
  • Assure the timely and appropriate close out of deviations and investigations involving partners and contractors
  • Working with interfacing departments propose and develop corrective and preventive actions to improve manufacturing process of quality systems
  • Assist in the coordination of change control at partner sites in respect to activities that have either a direct or indirect impact on Biogen Idec products
  • Ensure GMP compliant management of Biogen Idec documents at the partner sites
  • Assist in the preparation and review of regulatory filing and annual product review declarations with respect to activities at partners

Qualifications

At least 5 years in pharmaceutical or biopharmaceutical industry in a technically orientated role including experience of the validation of laboratory and production equipment.

Education

University degree in physical or biological science; postgraduate qualification preferred.