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.