Job Description
We are looking for a
Quality Manager in Quality Engineering for Equipment Qualification (m/f)
Office based in Solothurn
What you expect:
The quality department Quality Engineering (QE) represents a part of Quality Unit Bio DS in Solothurn and is mainly focused on quality assurance tasks with respect to system qualification and in certain cases CSV has also to be covered.
As QE Manager you will report to the Head of Quality Engineering.
Your main responsibilities will be:
• Supporting all qualification activities according Biogen procedures and system release.
• Close interaction with different parties (Validation, Engineering, Manufacturing Science, QA OPS and QE CSV)
• System walk downs against P&ID and review qualification documents against design documents
• Supporting and perform Risk assessments
• Supporting Deviation, CAPA and Change Management
• Supporting or lead of projects supporting interdisciplinary interactions
• Moderation or leading of Risk Assessments (e.g. FMEA)
• Performing internal audits or supporting external Audits
• Support or SME representative during Audits and Inspections
• Execution of trainings
Who you are:
You are open for new ideas and strategies and you are challenging conventional paradigms. You like to work in a challenging environment where collaboration is supported by respect and discussions.
For this position you need the following qualification:
Qualifications
• Fundamental knowledge in Computerized System Validation (CSV)
• At least 3 years of experience in Quality Management and GMP manufacturing environment (e.g. Bio DS, Bio DP or SM DP)
• Very good communication style and decisive driven personality with a high level of persuasiveness
• Acts very independently as also in represents a very good team player.
• High level of analytical skills, recognizes connections and influencing factors
• High knowledge in Risk Management
• Very good computer knowledge in Word, PowerPoint, Excel, etc. Knowledge in Trackwise is advantageous
• Additional education in Quality-Management (e.g. in Lean Six Sigma) are advantageous
• English fluent in written and spoken (additionally in German is advantageous)
Education
• Finished master study with a nature science, technical background (e.g. Bioengineering, Pharmacy) or equivalent with several years of experience in qualification and validation.