ten23 health
QA for QC Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahren
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
D-D-ploy
Qualification Expert (Computer-based Lab Systems, Pharma)(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Computer-based system qualification for pharma clients, including URS and HLRA. Big pharma and GxP experience required. Lunch checks and Reka money.
Anforderungen
- Big pharma experience
- Document creation experience
- GxP experience
- IO OQ PQ basic experience
- Working knowledge of qualification processes
- Working knowledge of Computer System Validation concepts
- Good understanding of regulated environments
- Motivation for working in regulated environments
- GxP methodologies knowledge
- 21 CFR Part 11 compliance knowledge
- ALCOA+ principles knowledge
- Latest industry expectations for Data Integrity knowledge
- Lab environment knowledge (advantageous)
- ITIL knowledge (advantageous)
- IT knowledge (advantageous)
- Excellent communication skills with client
- Excellent communication skills with 3rd party
- Excellent communication skills with project manager
- Excellent communication skills with team members
- Proven ability to prioritize demands
- Proven ability to manage multiple demands
- Proven ability to prioritize projects
- Proven ability to manage multiple projects
- Proven ability to prioritize cross-functional teams
- Proven ability to manage cross-functional teams
- Experienced in technical writing
- Experienced in instructional design
- Experienced in technical editing
- Experienced in copy editing
- Experienced in proofreading
- Experienced in quality assurance
- Good at gathering feedback
- Good at implementing improvements
- Self-responsible
- Self-organized
- Flexible person
- Multi-tasking
- Handling changes in requirements
- Handling changes in schedule
- Willingness to work at different customer locations
- Candidates must provide Criminal record extract
Aufgaben
- Prepare computer-based system qualification deliverables
- Execute computer-based system qualification deliverables
- Develop project plans for system qualification
- Conduct High-Level Risk Assessments (HLRA)
- Define User Requirement Specifications (URS)
- Create Qualification Plans (QPlan)
- Perform Installation Qualification (IQ)
- Perform Operational Qualification (OQ)
- Perform Performance Qualification (PQ)
- Conduct Electronic Records and Signatures (ERES) assessments
- Perform ERES verification
- Generate Qualification Reports (Q-Report)
- Conduct risk assessments for systems
- Develop decommissioning test plans
- Create Standard Operating Procedures (SOPs)
- Review qualification deliverables from team members
- Migrate computer-based lab equipment systems
- Migrate operating systems for lab equipment
- Migrate data for lab equipment systems
- Provide IT support for onsite lab personnel
- Troubleshoot system configuration issues
- Assist Service Coordinators with project delivery
- Assist Service Delivery Managers with project delivery
- Manage project timelines and budgets
- Act as Subject Matter Expert for qualification
- Serve as Point of Contact for regulatory inspections
- Serve as Point of Contact for audits
- Support colleagues onsite
- Deputize for colleagues onsite
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – fließend
Tools & Technologien
- GxP
- IO OQ PQ
- Computer System Validation
- 21 CFR Part 11
- ALCOA+
- Data Integrity
- ITIL
Benefits
Gratis oder Vergünstigte Mahlzeiten
- Lunch Checks
Sonstige Vorteile
- Reka Money
Snacks & Getränke
- Free refreshments
Mitarbeiterrabatte
- Insurance benefits
Boni & Prämien
- Referral program
Weiterbildungsangebote
- Professional development
Karriere- und Weiterentwicklung
- Professional advancement
Lockere Unternehmenskultur
- Friendly working environment
- International working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens D-ploy erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- D-ploy
Lab IT Technician(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - CH12 Lonza AG
QC Lab Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Datalynx AG
IT Quality Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Pharmatronic AG
Project- and Qualification-Engineer(m/w/x)
Vollzeitnur vor OrtManagementPratteln
D-D-ploy
Qualification Expert (Computer-based Lab Systems, Pharma)(m/w/x)
Basel
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Computer-based system qualification for pharma clients, including URS and HLRA. Big pharma and GxP experience required. Lunch checks and Reka money.
Anforderungen
- Big pharma experience
- Document creation experience
- GxP experience
- IO OQ PQ basic experience
- Working knowledge of qualification processes
- Working knowledge of Computer System Validation concepts
- Good understanding of regulated environments
- Motivation for working in regulated environments
- GxP methodologies knowledge
- 21 CFR Part 11 compliance knowledge
- ALCOA+ principles knowledge
- Latest industry expectations for Data Integrity knowledge
- Lab environment knowledge (advantageous)
- ITIL knowledge (advantageous)
- IT knowledge (advantageous)
- Excellent communication skills with client
- Excellent communication skills with 3rd party
- Excellent communication skills with project manager
- Excellent communication skills with team members
- Proven ability to prioritize demands
- Proven ability to manage multiple demands
- Proven ability to prioritize projects
- Proven ability to manage multiple projects
- Proven ability to prioritize cross-functional teams
- Proven ability to manage cross-functional teams
- Experienced in technical writing
- Experienced in instructional design
- Experienced in technical editing
- Experienced in copy editing
- Experienced in proofreading
- Experienced in quality assurance
- Good at gathering feedback
- Good at implementing improvements
- Self-responsible
- Self-organized
- Flexible person
- Multi-tasking
- Handling changes in requirements
- Handling changes in schedule
- Willingness to work at different customer locations
- Candidates must provide Criminal record extract
Aufgaben
- Prepare computer-based system qualification deliverables
- Execute computer-based system qualification deliverables
- Develop project plans for system qualification
- Conduct High-Level Risk Assessments (HLRA)
- Define User Requirement Specifications (URS)
- Create Qualification Plans (QPlan)
- Perform Installation Qualification (IQ)
- Perform Operational Qualification (OQ)
- Perform Performance Qualification (PQ)
- Conduct Electronic Records and Signatures (ERES) assessments
- Perform ERES verification
- Generate Qualification Reports (Q-Report)
- Conduct risk assessments for systems
- Develop decommissioning test plans
- Create Standard Operating Procedures (SOPs)
- Review qualification deliverables from team members
- Migrate computer-based lab equipment systems
- Migrate operating systems for lab equipment
- Migrate data for lab equipment systems
- Provide IT support for onsite lab personnel
- Troubleshoot system configuration issues
- Assist Service Coordinators with project delivery
- Assist Service Delivery Managers with project delivery
- Manage project timelines and budgets
- Act as Subject Matter Expert for qualification
- Serve as Point of Contact for regulatory inspections
- Serve as Point of Contact for audits
- Support colleagues onsite
- Deputize for colleagues onsite
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – fließend
Tools & Technologien
- GxP
- IO OQ PQ
- Computer System Validation
- 21 CFR Part 11
- ALCOA+
- Data Integrity
- ITIL
Benefits
Gratis oder Vergünstigte Mahlzeiten
- Lunch Checks
Sonstige Vorteile
- Reka Money
Snacks & Getränke
- Free refreshments
Mitarbeiterrabatte
- Insurance benefits
Boni & Prämien
- Referral program
Weiterbildungsangebote
- Professional development
Karriere- und Weiterentwicklung
- Professional advancement
Lockere Unternehmenskultur
- Friendly working environment
- International working environment
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens D-ploy erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
D-ploy
Branche
IT
Beschreibung
D-ploy ist ein IT- und Engineering Solutions Unternehmen, das innovative IT-Services und -Lösungen für führende Industrieunternehmen liefert.
Noch nicht perfekt?
- ten23 health
QA for QC Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBasel - D-ploy
Lab IT Technician(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - CH12 Lonza AG
QC Lab Systems Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Datalynx AG
IT Quality Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Pharmatronic AG
Project- and Qualification-Engineer(m/w/x)
Vollzeitnur vor OrtManagementPratteln