Posted 3 days ago
QA Manager, QA Analytics 80-100% (f/m/d)
AI Summary
QA Manager within QA Analytics at Lonza Biologics, ensuring QC processes comply with GxP, data integrity, and regulatory requirements while serving as a key interface between QC and QA Operations.
About this role
Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
The QA Manager (f/m/d) within QA Analyticsis ensuring that all processes within the QC functional areas comply with GxP, data integrity and regulatory requirements as well with internal/external quality standards. As a Quality and Compliance representative for particular functional area, you are a key member in cross-functional teams, serving as an interface between QC and QA Operations and interact with senior stakeholders across the site.
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:
Represent QAAnalytics in cross-functional teams and meetings
RepresentQA concerns to the Quality Control (QC) and ensure thatGxPrequirements are met andglobal/local procedures(SOP)are followed
Review andapproveQC/AD related documents(e.g.method transfer documents, method validation documents, SOP, etc.)
Review andapproveTW records related to QC processes
EnsureQCdeviations/investigationsare appropriately investigated anddocumented following regulatory requirements
Actas decision-makerduring QC deviations/investigation process
Responsible to driveQA Analytics and QC relatedCAPA and EffectivenessCheckitems to completion andtimelyclosing
Ensure that documents are correct and adhere to SOPs and tocustomer’srequirements
Represent specificfunctionalareas asQA AnalyticsSubject Matter Expert (SME) and provideguidance and recommendations in these areas to internal or externalstakeholders
Supportanddrivespecific projects as well as reviseand approveSOPs
Support QCduring regulatory inspectionsandcustomer audits.
What we are looking for:
Academic degree in Chemistry/Biochemistry/Biotechnology/ Life Science or related field
Profound working experiencein the pharmaceutical industry within QC/QA required
Founded analyticalexpertiseand experience with analytical method validation, change management, deviation management andOOxinvestigations
Strong background in cGMP regulations, incl. USP, European and Japanese Pharmacopeia
Auditing experience and experience in interaction with Health Authorities (FDA, Swissmedic)
Experience in working in cross-functionalteams
Excellent verbal and written communication in English required; German isadvantageous.
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.
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