Location: The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
We are currently looking for a Senior QA Specialist (f/m/d) Process Validation for the expansion of our team here at our site in Visp In this role, you will be QA responsible for the compliance of process validation with main focus on Small Molecules including validation activities at scale, continued process verification and Product Quality Reviews (PQRs).
What you will 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
The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits
What you will do:
Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to Lonza procedures, and in compliance with regulatory guidance
Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
Leading the process validation teams including communication with customers
Preparation of the validation protocols and reports for the studies performed at manufacturing scale
Assessment of changes and deviations during manufacturing for their impact on validation
Preparation and maintenance of a documented continued process verification plan
What we are looking for:
Academic degree in Chemistry or any related field
Significant experience in the area of small molecules manufacturing, preferably in a validation function as well as strong background in cGMP
Broad knowledge of manufacturing processes in GMP environment
Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)
Fluency in English language is required; good German language skills are preferred
Managing internal and external customer relations professionally and effectively
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
