AVAILABLE Computer Systems Validation Specialist CSV, IT Quality Management, Technical Writing, Project Quality Manager PQM, GxP, GMP, 21 CFR Part 11
Aktualisiert am 30.07.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 30.07.2024
Verfügbar zu: 100%
davon vor Ort: 40%
Computerized System Validation
Project Quality
IT Quality
IQ
OQ
PQ
GxP
KNEAT
HP ALM
AGILE methodology
21 CFR
SDLC
Test script
Good Documentation Practice
Risk Assessment
FMEA
IT Control Frameworks
SAP Validation
Acceptance Test
Good Manufacturing Practice
Installation Qualification
Technical Documentation
CSV
English
Muttersprache
German:
A2, B1

Einsatzorte

Einsatzorte

Basel (+75km)
Schweiz
möglich

Projekte

Projekte

1 year 7 months
2021-12 - 2023-06

Veeva Vault QMS and Spotfire Dashboard upgrades and enhancements validation

Technical Writer and CSV Engineer csv KNEAT Testmanagement ...
Technical Writer and CSV Engineer
  • Subprojects included Distribution, Product Quality Complaints, Late Case Reporting, Engineering Docs, Issue Escalation, Batch Disposition.
  • Utilized KNEAT for document creation, test script execution, discrepancy management, and reviews. Employed ServiceNow for application change Control management.

Veeva Vault
csv KNEAT Testmanagement QMS
Moderna
Basel
1 year 2 months
2020-10 - 2021-11

Computer Systems Remediation and Validation of DeltaV Automation Control Systems

Computer Systems Validation Engineer (External Consultant)
Computer Systems Validation Engineer (External Consultant)
  • Created test plans and scripts in KNEAT.
  • Qualified equipment, including standard and custom-built systems with software components, validated test software for DCS and MES systems as per CSV Validation Plan. 
  • Conducted software tests, generated reports, performed risk analysis, and participated in QMS activities like change control and deviations review/approval.

Biogen
Luterbach, Solothurn, Switzerland
7 months
2019-07 - 2020-01

CellChain Gene Therapy Program (A Novartis ?Crown Jewels? Program)

Senior Project Quality Manager (External Consultant)
Senior Project Quality Manager (External Consultant)
  • Timely execution of project documentation via Document Navigator:
    • Authored validation plan, reviewed/approved test plan, architecture document, etc.
  • Improved compliance with project controls maturity assessment, maintained high-quality standards in test script review and approval using HP ALM, successfully executed Tollgate activities.
Novartis
Basel Campus, Basel, Switzerland
9 months
2018-07 - 2019-03

Actelion to JnJ Integration

Validation and Qualification Engineer (External Consultant)
Validation and Qualification Engineer (External Consultant)
  • Conducted remediation, validation, integration, and migration of GxP applications from Actelion to Johnson and Johnson post-acquisition, created and published validation plans and reports, conducted gap analysis and remediation of 21CFR Part11 gaps, utilized HP ALM for managing testing activities in UAT and Data migration.
  • Developed test Protocols and Plans, reviewed and approved Test Scripts manually and in HP ALM.
Actelion, A Janssen Pharmaceutical Company of Johnson and Johnson
Allschwil, Switzerland
9 months
2017-11 - 2018-07

#nucleus (SAP) - Large SAP project to harmonise IT and Business processes.

Validation Engineer (External Consultant)
Validation Engineer (External Consultant)
  • Validated site and country rollouts across Italy, Poland, and the Caribbean.
  • Reviewed and approved User Requirement Specifications (URS), created tests protocols and plans, developed compliance and validation plans and reports, reviewed and approved test scripts pre and post execution, successfully remediating defects.
Fresenius
Sarnen, Switzerland

Aus- und Weiterbildung

Aus- und Weiterbildung

1 year 2 months
2023-07 - now

development training

Interactive Consulting Plus GmbH, Dübendorf, Switzerland
Interactive Consulting Plus GmbH, Dübendorf, Switzerland
  • Attending a personal development training focusing on Communication and Presentation Skills
  • Preparing for certification exam on ISO/IEC 27001
  • Intensives Deutsch? (B1 ? Level) Sprachschule K5 Kurszentrum, Basel, Switzerland
3 months
2020-07 - 2020-09

intensive German Language course

A1 Goethe German PASS, NSH Bildungszentrum, Basel, Switzerland
A1 Goethe German PASS
NSH Bildungszentrum, Basel, Switzerland

Position

Position


Kompetenzen

Kompetenzen

Top-Skills

Computerized System Validation Project Quality IT Quality IQ OQ PQ GxP KNEAT HP ALM AGILE methodology 21 CFR SDLC Test script Good Documentation Practice Risk Assessment FMEA IT Control Frameworks SAP Validation Acceptance Test Good Manufacturing Practice Installation Qualification Technical Documentation CSV

Schwerpunkte

CSV
IT Quality
Validation
Technical Writing
Veeva Vault
KNEAT
HP ALM


Produkte / Standards / Erfahrungen / Methoden

My Profile

Since 2002, I've excelled in quality and compliance including validating computer systems crucial for Pharma, Medical Devices, and Life Sciences, ensuring that GMP manufacturing systems and GxP environments comply with quality standards. Skilled in supporting regulated IT infrastructure and fostering collaboration with team cooperation of business leaders, process owners and experts. Adept at supporting Projects whilst working close to the customer. Experienced in SAP validation and data migration.


My Contribution

  • Creation, review and approval of validation and project lifecycle documents.
  • Managing the CSV aspects ensuring robust and defendable validation.
  • Proficiency in refining existing documents to enhance their overall clarity and effectiveness.
  • Coaching and supervising of testers in good documentation practices, according to industry best practices.
  • Previously engaged in remote transactions to ensure compliance to regulatory processes and generate test evidence through proficient English language conversion.

Branchen

Branchen

  • Pharma
  • Medical Device
  • Biotech
  • Life Sciences

Einsatzorte

Einsatzorte

Basel (+75km)
Schweiz
möglich

Projekte

Projekte

1 year 7 months
2021-12 - 2023-06

Veeva Vault QMS and Spotfire Dashboard upgrades and enhancements validation

Technical Writer and CSV Engineer csv KNEAT Testmanagement ...
Technical Writer and CSV Engineer
  • Subprojects included Distribution, Product Quality Complaints, Late Case Reporting, Engineering Docs, Issue Escalation, Batch Disposition.
  • Utilized KNEAT for document creation, test script execution, discrepancy management, and reviews. Employed ServiceNow for application change Control management.

Veeva Vault
csv KNEAT Testmanagement QMS
Moderna
Basel
1 year 2 months
2020-10 - 2021-11

Computer Systems Remediation and Validation of DeltaV Automation Control Systems

Computer Systems Validation Engineer (External Consultant)
Computer Systems Validation Engineer (External Consultant)
  • Created test plans and scripts in KNEAT.
  • Qualified equipment, including standard and custom-built systems with software components, validated test software for DCS and MES systems as per CSV Validation Plan. 
  • Conducted software tests, generated reports, performed risk analysis, and participated in QMS activities like change control and deviations review/approval.

Biogen
Luterbach, Solothurn, Switzerland
7 months
2019-07 - 2020-01

CellChain Gene Therapy Program (A Novartis ?Crown Jewels? Program)

Senior Project Quality Manager (External Consultant)
Senior Project Quality Manager (External Consultant)
  • Timely execution of project documentation via Document Navigator:
    • Authored validation plan, reviewed/approved test plan, architecture document, etc.
  • Improved compliance with project controls maturity assessment, maintained high-quality standards in test script review and approval using HP ALM, successfully executed Tollgate activities.
Novartis
Basel Campus, Basel, Switzerland
9 months
2018-07 - 2019-03

Actelion to JnJ Integration

Validation and Qualification Engineer (External Consultant)
Validation and Qualification Engineer (External Consultant)
  • Conducted remediation, validation, integration, and migration of GxP applications from Actelion to Johnson and Johnson post-acquisition, created and published validation plans and reports, conducted gap analysis and remediation of 21CFR Part11 gaps, utilized HP ALM for managing testing activities in UAT and Data migration.
  • Developed test Protocols and Plans, reviewed and approved Test Scripts manually and in HP ALM.
Actelion, A Janssen Pharmaceutical Company of Johnson and Johnson
Allschwil, Switzerland
9 months
2017-11 - 2018-07

#nucleus (SAP) - Large SAP project to harmonise IT and Business processes.

Validation Engineer (External Consultant)
Validation Engineer (External Consultant)
  • Validated site and country rollouts across Italy, Poland, and the Caribbean.
  • Reviewed and approved User Requirement Specifications (URS), created tests protocols and plans, developed compliance and validation plans and reports, reviewed and approved test scripts pre and post execution, successfully remediating defects.
Fresenius
Sarnen, Switzerland

Aus- und Weiterbildung

Aus- und Weiterbildung

1 year 2 months
2023-07 - now

development training

Interactive Consulting Plus GmbH, Dübendorf, Switzerland
Interactive Consulting Plus GmbH, Dübendorf, Switzerland
  • Attending a personal development training focusing on Communication and Presentation Skills
  • Preparing for certification exam on ISO/IEC 27001
  • Intensives Deutsch? (B1 ? Level) Sprachschule K5 Kurszentrum, Basel, Switzerland
3 months
2020-07 - 2020-09

intensive German Language course

A1 Goethe German PASS, NSH Bildungszentrum, Basel, Switzerland
A1 Goethe German PASS
NSH Bildungszentrum, Basel, Switzerland

Position

Position


Kompetenzen

Kompetenzen

Top-Skills

Computerized System Validation Project Quality IT Quality IQ OQ PQ GxP KNEAT HP ALM AGILE methodology 21 CFR SDLC Test script Good Documentation Practice Risk Assessment FMEA IT Control Frameworks SAP Validation Acceptance Test Good Manufacturing Practice Installation Qualification Technical Documentation CSV

Schwerpunkte

CSV
IT Quality
Validation
Technical Writing
Veeva Vault
KNEAT
HP ALM


Produkte / Standards / Erfahrungen / Methoden

My Profile

Since 2002, I've excelled in quality and compliance including validating computer systems crucial for Pharma, Medical Devices, and Life Sciences, ensuring that GMP manufacturing systems and GxP environments comply with quality standards. Skilled in supporting regulated IT infrastructure and fostering collaboration with team cooperation of business leaders, process owners and experts. Adept at supporting Projects whilst working close to the customer. Experienced in SAP validation and data migration.


My Contribution

  • Creation, review and approval of validation and project lifecycle documents.
  • Managing the CSV aspects ensuring robust and defendable validation.
  • Proficiency in refining existing documents to enhance their overall clarity and effectiveness.
  • Coaching and supervising of testers in good documentation practices, according to industry best practices.
  • Previously engaged in remote transactions to ensure compliance to regulatory processes and generate test evidence through proficient English language conversion.

Branchen

Branchen

  • Pharma
  • Medical Device
  • Biotech
  • Life Sciences

Vertrauen Sie auf Randstad

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

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