Senior QA Specialist, QA Operations 80-100% (m/f/d)
Location:the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Senior QA Specialist (m/f/d)is responsible for supporting the Associate Director, Head of QA Operations BioAtrium in setting up a strong and innovative team that is perceived as a main contributor to the success of the large scale mammalian operations in our future BioAtrium site. A great candidate will have strong leadership capabilities, envisioning and driving teamwork, quality culture, and innovation with the goal of becoming a role model within Lonza. We are looking for someone comfortable working in a matrix organization, effective with cross-functional and global projects, someone who can conceptualize where we need to be, how to get there, and drive ideas to completion. The key stakeholders that the Senior QA Specialist will work closely with the QA Operations team (including QA for QC and QA On The Floor), other QA teams and will interact with the the other Operational teams at BioAtrium like Production, Engineering and Project Management.
What you’ll get:
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
A variety of benefits dependant on role and location
Comply with, develop, implement and monitor quality procedures to ensure compliance with GxP standards, corporate policies, Swissmedic, FDA and other regulatory body regulations and guidelines.
Support all QA operations activities concerning SOP landscape, electronic batch records, training, deviation- / CAPA- and change control management
Support all audits and inspections
Identify and implement Lean / OPEX approaches in Quality and foster improvement projects
Provide KPI reporting and execute action plans to address opportunities for improvement
Work collaboratively with QA Operations and QA department colleagues
Support the Associate Director, Head of QA Operations BioAtrium and act as delegate.
What we’re looking for :
Academic degree in a Life Science discipline, Engineering or Quality Management or related field
P rofound and varied experience in a range of QA activities
Audit experience with Swissmedic/FDA/EMA regulations
Experience with Lean / Operational Excellence / Six Sigma
GMP compliance expertise
Ability to interface and communicate directly with customers and regulatory bodies
Excellent written and oral communication to include accurate and legible documentation
Ability to work on call
Fluent English is required, German language skills would be preferred
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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