The actual location of this job is in
Stein, AG, Switzerland . Relocation assistance is available for eligible candidates and their families, if needed.
Play a key role in keeping sterile manufacturing running safely and smoothly, working closely with production teams to spot issues early and turn them into improvements. This is a hands‑on role with real impact, offering visibility on the shop floor, strong collaboration across teams, and the chance to shape a positive, proactive quality culture. In order to be close to the process you will be working in a cleanroom environment several times a week (preferably daily. Check out Your Career in Drug Product Services at Lonza!
What you will get:
An agile career and a dynamic work culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.
Benefits in Stein: https://bit.ly/42DlBDk
What you will do:
Establish and maintain Quality Oversight for DPS Manufacturing, with a strong focus on aseptic/sterile manufacturing, environmental monitoring, process simulations (APS), visual inspection and personnel qualification. Act as a quality advisor and business partner to manufacturing and internal stakeholders on GMP and compliance topics.
Ensure effective implementation and ownership of the GMP Quality System in Sterile Production Stein, including SOP ownership and quality oversight activities.
Review and approve quality protocols, reports, and EM trending, including APS, cleaning and holding time studies, and equipment/room qualifications.
Oversee GMP‑compliant material and personnel flows within sterile manufacturing operations.
Lead and execute GMP compliance activities, including change control, deviations, document management, among others. Support and lead quality-related projects, continuous improvement initiatives and development of QA tools and processes.
Represent QA during inspections, audits, and self‑inspections, as well as in local and global quality initiatives.
Serve as the primary QA contact for sterile manufacturing compliance issues
What we are looking for:
Solid experience in the GMP controlled environment in Quality Assurance or Aseptic manufacturing
You have a sound experience in deviation handling, ideally certified for deviation handling
Experience in QA manufacturing oversight is preferred
Fluency in German & fluency in English is a must
Willing to work in shifts
Willing to be present in the manufacturing area in the cleanroom (full gowning is necessary) preferably daily
#J-18808-Ljbffr
Stein, AG, Switzerland . Relocation assistance is available for eligible candidates and their families, if needed.
Play a key role in keeping sterile manufacturing running safely and smoothly, working closely with production teams to spot issues early and turn them into improvements. This is a hands‑on role with real impact, offering visibility on the shop floor, strong collaboration across teams, and the chance to shape a positive, proactive quality culture. In order to be close to the process you will be working in a cleanroom environment several times a week (preferably daily. Check out Your Career in Drug Product Services at Lonza!
What you will get:
An agile career and a dynamic work culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.
Benefits in Stein: https://bit.ly/42DlBDk
What you will do:
Establish and maintain Quality Oversight for DPS Manufacturing, with a strong focus on aseptic/sterile manufacturing, environmental monitoring, process simulations (APS), visual inspection and personnel qualification. Act as a quality advisor and business partner to manufacturing and internal stakeholders on GMP and compliance topics.
Ensure effective implementation and ownership of the GMP Quality System in Sterile Production Stein, including SOP ownership and quality oversight activities.
Review and approve quality protocols, reports, and EM trending, including APS, cleaning and holding time studies, and equipment/room qualifications.
Oversee GMP‑compliant material and personnel flows within sterile manufacturing operations.
Lead and execute GMP compliance activities, including change control, deviations, document management, among others. Support and lead quality-related projects, continuous improvement initiatives and development of QA tools and processes.
Represent QA during inspections, audits, and self‑inspections, as well as in local and global quality initiatives.
Serve as the primary QA contact for sterile manufacturing compliance issues
What we are looking for:
Solid experience in the GMP controlled environment in Quality Assurance or Aseptic manufacturing
You have a sound experience in deviation handling, ideally certified for deviation handling
Experience in QA manufacturing oversight is preferred
Fluency in German & fluency in English is a must
Willing to work in shifts
Willing to be present in the manufacturing area in the cleanroom (full gowning is necessary) preferably daily
#J-18808-Ljbffr
