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Senior qa specialist, microbial contamination control & cleaning 80-100% (f/m/d)

Stalden (Obwalden)
Lonza
EUR 80’000 - EUR 100’000 pro Jahr
Inserat online seit: 9 Juni
Beschreibung

Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
This role offers the opportunity to lead and shape a comprehensive contamination control strategy within a GMP‑regulated bioconjugates environment, directly impacting product quality and patient safety. You will drive cross‑functional collaboration, leverage contamination control expertise, and influence continuous improvement initiatives to strengthen compliance and operational excellence.
Benefits: 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.
Lead the Bioconjugates contamination control strategy, ensuring end to end compliance across Bioconjugates manufacturing facilities.
Lead CCS‑related topics, such as bioburden control strategy, hygiene, environmental monitoring, etc. (managing Risk and Gap Assessments, Change Requests, Deviations, Investigations, CAPAs, etc.) in Bioconjugates.
Author and approve GMP documentation and records, including: SOPs, deviations, change controls, and risk assessments.
Partner closely with cross‑functional teams to identify risks, drive deviation management & continuous improvement, and strengthen contamination prevention control practices.
Lead the identification, assessment, and mitigation of contamination risks and maintaining the Contamination Control Strategy (CCS) within Bioconjugates.
Guide and influence stakeholders by providing microbiology and QA expertise, ensuring robust quality culture and operational compliance.
Act as QA Microbial Contamination Control and cleaning SME in meetings with the relevant stakeholders, and customers, in audits and inspections.
Review and approving the routine cleaning‑relevant documents, i.e., routine cleaning plans and reports, MAC plans and cleaning QC plans.
Responsible for the review and final release of records like Standard Operating Procedures (SOPs), Master Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
Identify emerging QA relevant topics, communicating to the relevant stakeholders and working actively on their development into new or already established Quality and Compliance strategies and/or standards i.e., CAPAs.
Support continuous improvement programs to establish effective Quality Contamination Control.
Qualifications: Academic degree in Chemistry/Biotechnology/ Life Science or related field.
Extensive experience in the GMP‑regulated pharmaceutical industry; experience in microbial contamination control and Environmental Monitoring programs with practical understanding is required.
General knowledge of manufacturing processes, contamination control strategy, cleaning procedures and analytical methods.
Demonstrated ability to act proactively with a detail‑oriented, problem‑solving and continuous‑improvement mindset.
Experience in the interaction with health authorities (Swissmedic, FDA etc.) is desired.
We are looking for someone who is independent, sociable, pro‑active, customer focused and who values working as a team player.
Experience with TrackWise, SAP, and Microsoft Office software is preferred.
Fluency in English is required; German would be an asset.

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