Lonza
QA Project Manager - Drug Product 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.
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:Establish Quality Agreements (QAA) in close collaboration with Drug Product Services DPS in Basel / Stein and LONZA Drug Substance (DS) sites (e.g. Slough / Visp).
Act as QA representative in Project teams and represent QA in customer meetings during Technical Transfer.
Act as QA contact for specific projects and realize the interface for DRs and CRs with the customer (routine follow-up’s).
Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations.
Organize customer audits together with the Visp Compliance team and DPS Basel functions.
Support and approve project / product specific risk assessments or regulatory specific risk or gap assessments.
Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
Work closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI).
Support general organization of inspections (front / back office).
Represent Drug Product QA topics during regulatory inspections.
Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.
Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.
What we are looking for:
University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
Long-term experience working in the GMP environment of the pharmaceutical industry
Experience working in a QA department would be an advantage
Business fluent English is required, German language skills are an advantage
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.