ten23 health
QA for QC Expert(m/w/x)
Full-time/Part-timeOn-siteExperienced
Basel
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Qualification Expert (Computer-based Lab Systems, Pharma)(m/w/x)
Basel
Full-timeOn-siteExperienced
Nejo AI Summary
Computer-based system qualification for pharma clients, including URS and HLRA. Big pharma and GxP experience required. Lunch checks and Reka money.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
- German – Fluent
Tools & Technologies
- GxP
- IO OQ PQ
- Computer System Validation
- 21 CFR Part 11
- ALCOA+
- Data Integrity
- ITIL
Benefits
Free or Subsidized Food
- Lunch Checks
Other Benefits
- Reka Money
Snacks & Drinks
- Free refreshments
Corporate Discounts
- Insurance benefits
Bonuses & Incentives
- Referral program
Learning & Development
- Professional development
Career Advancement
- Professional advancement
Informal Culture
- Friendly working environment
- International working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of D-ploy and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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D-D-ploy
Qualification Expert (Computer-based Lab Systems, Pharma)(m/w/x)
Basel
Full-timeOn-siteExperienced
Nejo AI Summary
Computer-based system qualification for pharma clients, including URS and HLRA. Big pharma and GxP experience required. Lunch checks and Reka money.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degreeOR
- Master's degree
Languages
- English – Fluent
- German – Fluent
Tools & Technologies
- GxP
- IO OQ PQ
- Computer System Validation
- 21 CFR Part 11
- ALCOA+
- Data Integrity
- ITIL
Benefits
Free or Subsidized Food
- Lunch Checks
Other Benefits
- Reka Money
Snacks & Drinks
- Free refreshments
Corporate Discounts
- Insurance benefits
Bonuses & Incentives
- Referral program
Learning & Development
- Professional development
Career Advancement
- Professional advancement
Informal Culture
- Friendly working environment
- International working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of D-ploy and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
D-ploy
Industry
IT
Description
D-ploy ist ein IT- und Engineering Solutions Unternehmen, das innovative IT-Services und -Lösungen für führende Industrieunternehmen liefert.
Not a perfect match?
- ten23 health
QA for QC Expert(m/w/x)
Full-time/Part-timeOn-siteExperiencedBasel - D-ploy
Lab IT Technician(m/w/x)
Full-timeOn-siteExperiencedBasel - CH12 Lonza AG
QC Lab Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedBasel - Pharmatronic AG
Project- and Qualification-Engineer(m/w/x)
Full-timeOn-siteManagementPratteln - F. Hoffmann-La Roche AG
QC GMP Expert:in(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst