29.07.2026 aktualisiert

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Senior QA/CSV Consultant

Switzerland, Schweiz
Weltweit
Genetics (Molecular Biology) and Electronics (Technical Informatics)
Switzerland, Schweiz
Weltweit
Genetics (Molecular Biology) and Electronics (Technical Informatics)

Profilanlagen

CV_Bernhard Brodowicz_2026_07_A.pdf

Über mich

Experienced Senior QA and CSV Consultant with over a decade of expertise delivering GxP-compliant validation solutions for pharmaceutical, biotech, and medical device companies.

Skills

21 CfrAuditsBiotechnologieKorrektur- und VorbeugemaßnahmeChange ControlKollaborationsplattformComplianceDatenvalidierungDatenintegritätProjektmanagementQualitätsmanagementMicrosoft SharepointVerifizierung und ValidierungValidierungstestsIq/oq/pqBeurteilungen DurchführenValidierungsprotokolleAbweichungsmanagementSystem-ImplementierungenGerätequalifizierungMicrosoft TeamsVirtuelle TeamsGmp-gerechte DokumentationProjektlieferungValidierung von ErgebnissenGXP
Professional Summary

Experienced Senior QA and CSV Consultant with over a decade of expertise delivering GxP-compliant validation solutions for pharmaceutical, biotech, and medical device companies. Specialized in remote-first project delivery, managing cross-site teams to ensure inspection readiness and regulatory compliance (GAMP 5, EU Annex 11, 21 CFR Part 11). Proven ability to lead complex CSV strategies and data integrity remediations virtually, partnering effectively with international stakeholders to achieve audit-ready outcomes.

Core Competencies
  1. Remote CSV Strategy Development & Execution
  2. GAMP 5, EU Annex 11, 21 CFR Part 11 Compliance
  3. Data Integrity Remediation (Remote Assessments)
  4. Audit and Inspection Readiness (FDA, ANVISA, Swissmedic, AGES, Chinese FDA)
  5. Cross-Functional Virtual Team Leadership
  6. Change Control, CAPA, Deviation Management
  7. Validation Planning and Documentation (IQ/OQ/PQ)
  8. Project Management for Computerized System Implementations
  9. Remote Collaboration Tools (MS Teams, SharePoint, Veeva Vault, Kneat)

Sprachen

DeutschMutterspracheEnglischverhandlungssicherSpanischverhandlungssicher

Projekthistorie

Senior QA/CSV Consultant

Self Employed

Pharma und Medizintechnik

< 10 Mitarbeiter

  • Defined and implemented quality systems and CSV strategies for international clients, delivering projects primarily remotely. Ensured cGMP, EU GMP, ISO 9001, ISO 13485, 21 CFR Part 4/11, EU GMP Annex 11, and GAMP 5 compliance.
  • Led remote project management for CSV of ERP, DMS, BMS, and production systems.
  • Delivered audit and inspection readiness support for FDA, Swissmedic, and other agencies.
  • Partnered with QA and IT functions to deploy electronic systems and compliance solutions remotely.

Expert Production Quality

Switzerland

Industrie und Maschinenbau

>10.000 Mitarbeiter

• Independently perform analyses and risk assessments for deviations and complaints in production areas, including root-cause investigations
• Work with specialist departments to meet customer quality and control requirements in manufacturing.
• Support planning and implementation of corrective and preventive actions (CAPAs) resulting from production deviations.
• Ensured documentation integrity and compliance in production quality processes within a medical device / pharmaceutical manufacturing environment.

Consultant Analytical Equipment and Qualification

Idorsia Pharmaceuticals Ltd

Pharma und Medizintechnik

50-250 Mitarbeiter

  1. Led the project for decommissioning of the analytical GMP laboratories.
  2. Set up the strategy for decommissioning.
  3. Planned the resources and timelines.
  4. Managed the archiving and transfer of analytical data.

Consultant Equipment Qualification / CSV

Takeda Manufacturing Austria AG (Vienna, Austria - remote)

Pharma und Medizintechnik

>10.000 Mitarbeiter

  • Delivered remote qualification support for analytical instruments.
  • Risk assessments, URS development, and qualification protocol drafting.
  • Conducted 21 CFR Part 11 gap analysis and planned remediation activities.
  • Supported Audit Trail setup via 3rd-party software (SMART Audit Trail).

Senior QA Manager Instrument Qualification

Lonza Inc (Basel, Switzerland - hybrid)

Pharma und Medizintechnik

>10.000 Mitarbeiter

  • Implemented QA Activities Planning Tool (SharePoint-based).
  • Prepared for Swissmedic and FDA pre-approval inspections.
  • Conducted 6S-audits and led Gemba walks.
  • Oversaw activities for equipment qualification and CSV remotely and on-site.

Senior Quality Manager / Quality Consultant

Sanity Science GmbH / Vayamed GmbH (Hochheim am Main, Germany - remote)

Pharma und Medizintechnik

50-250 Mitarbeiter

  • Developed Validation Masterplan including remote CSV strategies.
  • Supported facility start-up and ERP, DMS, BMS, laboratory, and production system CSV remotely.
  • Delivered fully virtual compliance documentation for EU GMP certification readiness.

Team Leader Metrology & Lab Ops

Novartis - Sandoz (Unterach, Austria - hybrid)

Pharma und Medizintechnik

>10.000 Mitarbeiter

  • Led team of 5 (Metrology Experts and Lab Associates) with responsibility for task delegation,  staff development & training
  • Managed Capacity planning to ensure throughput of metrology and lab operations
  • Oversaw equipment lifecycle including CQV and CSV activities during site divestment
Achievements
Ensured compliant closure of development center, final qualifications, and data handovers under tight timelines.

Quality Assurance Manager Analytics & Stability

Novartis - Sandoz (Unterach, Austria)

Pharma und Medizintechnik

>10.000 Mitarbeiter

  • eCompliance (CSV-QA) Manager for SDC Unterach
  • Reviewed and approved analytical instrument qualifications, method validations, risk assessments and SOPs
  • Managed deviations, change controls, CAPAs; supported regulatory inspections

Achievements
Managed the completion of CSV and DI related remediation activities

Quality Assurance Manager / QiO Production & Lab (General) and Prefilled Syringes (PFS)

Novartis - Sandoz (Unterach, Austria)

Pharma und Medizintechnik

>10.000 Mitarbeiter

  • eCompliance Manager for IT, Production and QC Laboratory
  • Reviewed and approved process and cleaning validations, equipment qualifications, CSV of aseptic filling/inspection/packaging lines
  • Supported GxP activities on PFS production line ensuring audit readiness

Achievements
  • Successful FDA pre-approval inspection
  • Updated and validate Excel-Spreadsheets for data integrity compliance
  • Oversaw compliant CQV/CSV of Track&Trace and automated inspection systems

Quality Assurance Manager in Quality Control and R&D and Quality Control Manager

EVER Neuro Pharma GmbH (Unterach, Austria)

Pharma und Medizintechnik

250-500 Mitarbeiter

  • Implemented and validated (CSV) the LIMS and QM part of the ERP system
  • Led equipment qualification, method validation and transfer projects
  • Reviewed/approved experimental designs, risk analyses, validations
  • Conducted internal and external audits, supported authority inspections

Achievements
  • Updated user rights setup in the ERP system saving ~  € 200,000 EUR annually
  • Developed/validated an GxP Excel-Spreadsheet with automated data import

Research Associate - Receptor Biochemistry & Tumor Metabolism

CRCS GmbH, Paracelsus Medizinische Privatuniversität (Salzburg, Austria)

Sonstiges

250-500 Mitarbeiter

  • Research Associate - Receptor Biochemistry & Tumor Metabolism
  • Cultured human tumor cell lines, performed qRT-PCR, Western blot, HPLC, FACS
  • Supervised interns and master students

Achievements
  • Discovered galanin receptor expression on human immune/tumor cells
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