Senior QA Specialist, Batch Release 80-100% (f/m/d)
Senior QA Specialist, Batch Release 80-100% (f/m/d)
Lonza AG
Pharma, Medizintechnik
- Visp
- Vollzeit
- 67.500 CHF – 106.000 CHF (von XING geschätzt)
Vor Ort
Senior QA Specialist, Batch Release 80-100% (f/m/d)
Über diesen Job
Today, Lonza is a global leader in life sciences operating across five 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.
We are looking for a Senior QA Specialist, Batch Release (m/f/d) for the Mammalian Business Unit in Visp.
The Senior QA Specialist, ensures that manufactured products comply with national and international requirements and cGMP standards over their entire life cycle. As a Quality representative she/he will be a key member in cross-functional teams ensuring measures for product safety, product quality & cGMP compliance are implemented. The Senior QA Specialist will have the delegation from the Lonza Visp FvP and will be also responsible for the conditional releases.
W hat you’ll get:
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize high performance
Flexible working arrangements
What you’ll do:
Disposition of DS batches: Release/block/Reject of Drug Substance produced in DD DS (Mammalian) on behalf of the Responsible Person/ FvP ( Fachtechnisch verantwortlichte Person, FvP ) according to article 4, 5 and 7 AMBW
Grant conditional releases (SF) for raw materials and intermediates and authorization for quarantine shipments on behalf of the afore mentioned Responsible Person
Acts as QA expert (SME) for DS disposition and SF, providing recommendations and suggestions in these areas .
Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Quality Risk Assessments, Deviations, CAPAs, Change Requests, Effectiveness Checks, etc where applicable
Identify emerging QA relevant topics and work actively on their development into new or already established Quality and Compliance strategies and/or standards
Participate and support regulatory inspections and customer audits . You will be the SME for such topic also in front of inspectors and auditors where necessary
What we’re looking for:
University Degree in Biotechnology / Biology / Chemistry / Life Science or related field
Solid QA experience in GMP environment
Strong background in cGMP and broad knowledge in biotechnological manufacturing processes
Experience in the use of the following systems would be preferred: TrackWise , LIMS, DMS and SAP
Excellent communication skills with experience in interaction with all kind of interfaces within the organization and preferably also with regulatory agencies ( Swissmedic , FDA etc.)
Agile and lean mindset
Proficient written and spoken English, German knowledge is an advantage
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.