Senior Associate III, QA Downstream
About This Role
The Senior Associate III, QA Downstream will support the ongoing production and maintanance of the new Large Scale Manufacturing facility located in Luterbach, Switzerland.
It is a technically orientated role requireing experience of the validation of production equipment and knowledge of production methodology involved in biopharmaceutical drug substance production.
This role is responsible for Quality oversight on manufacturing process which includes but not limited to Deviation management, Change control, CAPA, deviations, Work order, batch review, protocols and documentation review in the scope of Facilities, utilities, equipment and Biogen Execution System (global and local computerized systems).
The QA will work with systems that control key functional, tactical and operational aspects within the Quality Assurance organization at the Biogen Solothurn Facility and will support QMS with authoring, review and approving.
This position requires cooperation with people at every level of the organization and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.
What You'll Do
- Provide support to manufacturing areas within the facility for deviations, root cause analysis and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.
- Review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory and Biogen Quality and Process systems.
- Act on internal and external audit as SME and response to potential observations.
- Ensure continuous improvement in perspective of making processes and systems more robust and compliant.
- Support on deliverable related to batch operations (WO review, batch review, KPIs definition and monitoring).
- Masters in Science / Engineering in Life Science or Technical discipline or equivalent experience.
- Approximately 12+ of experience in pharmaceutical or biotech manufacturing environment., preferably in Quality Assurance.
- Must have proficiencies with the GMPs and good knowledge of the QA operation, deviation management, change control management, validation knowledge and engineering knowledge.
- Demonstrated ability to work autonomously.
- Good oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively.
- Demonstrated problem solving skills.
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Powerpoint, Visio, etc.)
- Candidates with experience in drug substance (or API) and drug product are preferred.
- Experience in participating in pharmaceutical technology transfer team.
- Professional proficiency/fluent in English.
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts
