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For our client, an international company in Zürich, we are looking for a Quality Manager.
General Information:
Start date: ASAP/30.09.2024
End date: 31.03.2026
Extension: to be discussed
Workplace: Zürich
Home office: possible, hybrid role
Workload: 100%
Responsibilities:
Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products
Leads multisite assay transfers via providing assay transfer strategy and project management with internal and external laboratories
Serve as SME for analytical methods incl biological, molecularbiological and microbiological methods established in the commercial release testing laboratories
Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
Serve as in-house analytical / technical expert for troubleshooting and investigating laboratory issues
Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications
Represent Quality Control on technical product teams
Collaborate closely with in-house analytical / process technical expert for troubleshooting and investigating laboratory and manufacturing issues
Author/review/approve method validation/transfer protocols/reports and related SOP's
Coordinate and lead re-manufacturing of critical reagents for analytical methods
Author/review/approve quality control plans / qualification protocols/reports and re-test protocols/reports of critical reagents for analytical methods
Author/review/approve regulatory relevant documents related to analytical methods
Responsible for technical assessment of methods and changes to methods for compliance to GMP requirements, global Pharmacopeias, industry standards etc.
Create and enhance collaborative and trusting relationships with internal and external laboratories and internal SMEs and establish effective communication
Organize and lead cross functional team meetings with internal and external laboratories and SMEs
Your Profile:
Degree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a a minimum of 3 years experience within a QC laboratory or QA organization (with oversight of QC activities).
A thorough understanding of pharmaceuticyal QMSystems and respective guidelines and QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred.
Experience in vaccines and biologics manufacturing and testing and related guideline and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, preferred.
Strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses.
Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network.
Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects
Ability to work in teams
English is required, German beneficial
Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred
For our client, an international company in Zürich, we are looking for a Quality Manager.
General Information:
Start date: ASAP/30.09.2024
End date: 31.03.2026
Extension: to be discussed
Workplace: Zürich
Home office: possible, hybrid role
Workload: 100%
Responsibilities:
Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products
Leads multisite assay transfers via providing assay transfer strategy and project management with internal and external laboratories
Serve as SME for analytical methods incl biological, molecularbiological and microbiological methods established in the commercial release testing laboratories
Take ownership of analytical issues and drive closure quickly, correctly, and permanently for commercial products.
Serve as in-house analytical / technical expert for troubleshooting and investigating laboratory issues
Apply statistical analysis for data interpretation and apply chemometric principles to resolve complex analytical issues and applications
Represent Quality Control on technical product teams
Collaborate closely with in-house analytical / process technical expert for troubleshooting and investigating laboratory and manufacturing issues
Author/review/approve method validation/transfer protocols/reports and related SOP's
Coordinate and lead re-manufacturing of critical reagents for analytical methods
Author/review/approve quality control plans / qualification protocols/reports and re-test protocols/reports of critical reagents for analytical methods
Author/review/approve regulatory relevant documents related to analytical methods
Responsible for technical assessment of methods and changes to methods for compliance to GMP requirements, global Pharmacopeias, industry standards etc.
Create and enhance collaborative and trusting relationships with internal and external laboratories and internal SMEs and establish effective communication
Organize and lead cross functional team meetings with internal and external laboratories and SMEs
Your Profile:
Degree in microbiology, pharmaceutical science, biotechnology, chemistry or closely related field with a a minimum of 3 years experience within a QC laboratory or QA organization (with oversight of QC activities).
A thorough understanding of pharmaceuticyal QMSystems and respective guidelines and QC laboratory processes is required and experience in an outsourced manufacturing and testing environment is preferred.
Experience in vaccines and biologics manufacturing and testing and related guideline and knowledge of pharmaceutical cGMPs (US and EU) and CMC regulatory requirements, preferred.
Strong technical expertise in microbiology and microbial methods and instrumentation, and statistical methods for data analyses.
Experienced at leading and delivering successful Technology Transfer activities across the CMO and internal network.
Strong verbal & written communication skills (including presentation skills). Can effectively articulate complex technical issues to non-technical audience. Proven ability to clearly articulate technical issues concisely and deliver effective presentations on complex technical subjects
Ability to work in teams
English is required, German beneficial
Six Sigma Lean Laboratory, Greenbelt or Blackbelt Certification preferred
contattaci.
saremo felici di rispondere alle tue domande in merito a questa posizione.
Sai come funziona il nostro iter di selezione? Scopri come aiutiamo le persone a trovare il lavoro giusto.
1 di 8
candidati con Randstad.
Candidarsi alle nostre offerte di lavoro è facile. Dopo aver ricevuto la tua domanda di impiego, la verificheremo per capire se è linea con il ruolo professionale e l’azienda.
2 di 8
ti ricontatteremo.
Il nostro consulente ti contatterà a tempo debito per discutere la tua candidatura e futuri desideri di carriera.
3 di 8
per registrarti.
Se non hai ancora lavorato con noi, avremo bisogno di ulteriori informazioni di base per confermare la tua idoneità a lavorare in Svizzera.
4 di 8
verifica compatibilità, referenze e formazione.
Dovremo poi controllare un paio di dati – faremo le necessarie verifiche di compatibilità per assicurarci che tu sia il candidato ideale per il ruolo, contatteremo le referenze che ci hai trasmesso e ti aggiorneremo.
5 di 8
il lavoro perfetto per te.
Il nostro team di esperti organizzerà un colloquio per il profilo per cui ti sei candidato oppure, in caso di migliori opportunità, ti proporrà delle alternative.
6 di 8
il colloquio.
Ci assicureremo che tu sia perfettamente preparato ad affrontare il tuo colloquio e al corrente di quello che ti aspetta. Buona fortuna!
7 di 8
inizia il tuo nuovo impiego.
Congratulazioni! Sei pronto per iniziare il tuo nuovo impiego. Il team garantirà che tu sia perfettamente pronto ad affrontare il tuo primo giorno di lavoro.
8 di 8
supporto continuo.
Una volta iniziata la tua nuova sfida, ti contatteremo per vedere come procede e per assicurarci che tu abbia il nostro supporto nello svolgimento del tuo impiego.
We are recruiting for a Key Account Manager Vaccines (Part-Time, 50%), on behalf of our client, a leading international company based in Zurich. General Information:Start Date: October 1st, 2024, or as soon as possibleEnd Date: March 31st, 2025Location: Zurich, with frequent travel within German-speaking and French-speaking regions of Switzerland In this role, the successful candidate will be responsible for enhancing visibility and awareness of the dengue
We are recruiting for a Key Account Manager Vaccines (Part-Time, 50%), on behalf of our client, a leading international company based in Zurich. General Information:Start Date: October 1st, 2024, or as soon as possibleEnd Date: March 31st, 2025Location: Zurich, with frequent travel within German-speaking and French-speaking regions of Switzerland In this role, the successful candidate will be responsible for enhancing visibility and awareness of the dengue
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