Provide quality and technical guidance on product and manufacturing related issues
- Assist in the implementation of the Biogen Idec quality system in the Hillerød facility
- Oversee activities related to the review and approval of validation activities protocols.
- Support the daily function and process improvement of validation activities
- Review and edit process/ methods/ regulatory reports
- Provide quality and technical oversight of partnerships and critical suppliers
- Supply quality support to development activities in the international region
- Act as liaison between disposition groups and contract manufacturers
- Author and review sections of the Annual Product Reviews
- Serve as required on multifunctional Biogen Idec committees and teams as required
- Compile and report product trending and metric data
- Assure quality oversight and participation for critical investigations, specification management change control, technology transfer and method
- Provide support for Regulatory Inspections, as required.
- Assist in the performance and facilitation of internal and external audits of quality areas and suppliers for GMP compliance
- Proven ability to lead multi disciplinary teams
- Solid grounding in quality systems and knowledge of cGMP regulations
- Experience of validation of both manufacturing and analytical equipment and instrumentation,
- Knowledge of the validation of manufacturing control systems and applicable regulations
- Excellent oral and written communication skills in English
- Knowledge of office automation Word, Excel, Lotus Notes etc
- Good organisational skills
Bachelors degree in a relevant scientific discipline with a minimum of 10years technical experience in the biotech or pharmaceutical industry.