QA Sr. Associate Ii

Vor 2 Tagen

Luterbach, Schweiz Biogen Vollzeit

**Job Description** A**

**About This Role**

The Senior Associate II QA is being part of the Quality Compliance and Technical services team. This role is mainly responsible on Facility, Utilities and Equipment (FUE) Qualification and Validation at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/she is also responsible for the Quality oversight of the manufacturing facilities, engineering and utilities activities and local Biogen Execution Systems (BES) e.g., Delta V, Syncade and PLC driven equipment. The Solothurn site is intended to operate with a fully integrated electronic batch record.

The holder of this position will be responsible for the following activities:

- Ensure Facility, Utilities, Equipment or computerized systems Qualification and Cleaning/Sterilization Validation are successfully executed according to current GMP and regulatory policies.
- Review and approval of Validation, Engineering and Manufacturing documents during both project and operational phases of the site.
- Review and approval of GMP documentation and data for compliance to applicable procedures, regulatory and/or corporate guidance documents.
- Responsible for QE activities (protocols, deviations, change control and CAPAs) associated to facility, utilities, equipment qualification and Cleaning Validation, or computerized system Support on Quality system activities ( KPIs, metrics, local SME)

**What You'll Do**
- Executes QA activities related to facility, utilities, equipment qualification, cleaning validation to ensure the safety, efficacy and purity of the products manufactured by Biogen.
- Review and approve GMP documentation specifically related to validation protocols, procedures, CAPAs, deviations etc.
- Ensures adherence to internal procedures for facility/equipment and automation controls and release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New product introduction.

**Who You Are**

As an individual, you possess extensive experience in pharmaceutical or biotech manufacturing, coupled with proficiency in Quality systems, strong communication skills, and familiarity with productivity software. Your background includes hands-on involvement in drug substance and drug product manufacturing, including reviewing validation documents, ensuring compliance with GMP regulations, and overseeing Quality Assurance activities related to facility and equipment qualification.
**Qualifications**
- Bachelor’s degree in relevant field such as Chemical Engineering, Mechanical Engineering, Bioengineering, Automation Systems.
- 8 years of experience in pharmaceutical or biotech manufacturing environment. Experience with Quality Assurance, Equipment Qualification, Equipment Cleaning Validation, Automation/MES or related function is preferred.
- Must have proficiencies with the Quality systems and, preferably, with business processes associated with automation and integration of testing and production systems.
- Demonstrated ability to work autonomously with cross-functional team members.
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors, and external partners effectively.
- Strong presentation and organizational skills
- Demonstrated problem solving skills
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, PowerPoint, Visio, etc.)
- English B1 as a minimum.

**Additional Information**

**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

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