Aseptic manufacturing and process automation, Labware 8 experience and project management, Computerized System Validation, Non-conformance and CAPA
Aktualisiert am 12.02.2026
Profil
Mitarbeiter eines Dienstleisters
Remote-Arbeit
Verfügbar ab: 12.02.2026
Verfügbar zu: 100%
davon vor Ort: 100%
Skill-Profil eines fest angestellten Mitarbeiters des Dienstleisters

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

3 years 6 months
2018-09 - 2022-02

Head of Quality

Head of Quality
Head of Quality
  • Responsible for all GxP activities related to the subdivisions of the Quality (Quality Assurance, Validation and Quality Control), directing 5 managers and reporting to the Institute's president.
  • Hiring and building a team and organization that reached more than 350 people.
  • Responsible for the concepting and implementation of a new Quality Management System, designed according to international standards (FDA, WHO, EMA), with subsequent WHO approval for influenza vaccine.
  • Acting strategically and technically in aspects related to the production of vaccines and serum (aseptic manufacturing).
  • Conduct and define the strategies of the meetings that involved the participation of Brazilian regulatory agency (ANVISA), covering important routine matters and new projects (eg: Covid vaccine).
  • Acting as a Qualified Person for all products in the portfolio.
  • Member of steering committees working with international partners (Merck, GSK, SANOFI) in technology development and transfer.
  • Responsible for the modernization of the Quality Control laboratories (equipment, processes, and facilities), creating all necessary GAP assessments.
  • Execution of national and international audits, involving all Quality details (QA, QC and Validation activities).
  • Creation of Action Plans derived from national and international audits.
  • Direct action during the COVID pandemic, defining the necessary strategies to guarantee all aspects of Quality and obtain authorization from the regulatory agency while ensuring the vaccine supply chain.
  • As Head of Quality, I was the main responsible for all Quality aspects involving the Clinical Trials of the Covid-19 vaccine (Coronavac).
  • Company representative during the Brazilian government audit, carried out at production
Butantan Institute
Sao Paulo / Brasil

Position

Position

Senior consulting for internal and external projects related to all aspects of
Quality within the Pharmaceutical Industry (QMS, Validation, Laboratory),

such as:

  • Extensive experience with aseptic manufacturing and process automation.
  • Labware 8 experience and project management with customers
  • Master Data Management harmonization and definition support.
  • Different Computerized System Validation projects based on GAMP5.
  • Audit Readiness Project expert for customers.
  • Project Management and implementation of e-QMS (ex: SoftExpert and ZenQMS).
  • Harmonization and/or improvement of Quality SOPs.
  • Coordination of all measures and activities to improve the QMS and control of implementation activities.
  • Creation and implementation of QMS specific manuals and training concept with System Owner.
  • Planning, introduction, implementation and monitoring of procedures and processes for quality assurance.
  • Non-conformance and CAPA management.
  • Support in the GAMP5 validation of the e-QMS.
  • Planning, implementation, and monitoring of release tests for new services and products.
  • Participation in the creation and release of technical documentation.
  • Risk Assessment based on FMEA.
  • Technical support involving the validation activities related to the global Labware 8 LIMS application.
  • Master Data Migration Management and creation of Test Plans related to Master Data testing.
  • Supporting laboratories in process harmonization and compliance
  • Management of Test Plans within the ALM system, involving the upload of the plans and the approval flow.
  • Supporting all validation activities related to the global Labware 8 LIMS application.
  • Execution of comprehensive CSV GAP Assessments for systems such as Empower, Labware 8, COMOS, CMX and others.
  • FDA Audit Readiness compliance checks and preparation support.
  • Compliant setup of MES and SAP interfaces, including field mapping and Master Data Harmonization
  • FDA Audit Readiness project member and compliance consultant
  • Creation Review of CSV related validation documentation such as Test
  • Plans, Configuration Specification, Release Validation Plans and more.
  • Creation of a robust Validation strategy, considering the reality of the customer.
  • Validation strategy alignment with local and global stakeholders.

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

3 years 6 months
2018-09 - 2022-02

Head of Quality

Head of Quality
Head of Quality
  • Responsible for all GxP activities related to the subdivisions of the Quality (Quality Assurance, Validation and Quality Control), directing 5 managers and reporting to the Institute's president.
  • Hiring and building a team and organization that reached more than 350 people.
  • Responsible for the concepting and implementation of a new Quality Management System, designed according to international standards (FDA, WHO, EMA), with subsequent WHO approval for influenza vaccine.
  • Acting strategically and technically in aspects related to the production of vaccines and serum (aseptic manufacturing).
  • Conduct and define the strategies of the meetings that involved the participation of Brazilian regulatory agency (ANVISA), covering important routine matters and new projects (eg: Covid vaccine).
  • Acting as a Qualified Person for all products in the portfolio.
  • Member of steering committees working with international partners (Merck, GSK, SANOFI) in technology development and transfer.
  • Responsible for the modernization of the Quality Control laboratories (equipment, processes, and facilities), creating all necessary GAP assessments.
  • Execution of national and international audits, involving all Quality details (QA, QC and Validation activities).
  • Creation of Action Plans derived from national and international audits.
  • Direct action during the COVID pandemic, defining the necessary strategies to guarantee all aspects of Quality and obtain authorization from the regulatory agency while ensuring the vaccine supply chain.
  • As Head of Quality, I was the main responsible for all Quality aspects involving the Clinical Trials of the Covid-19 vaccine (Coronavac).
  • Company representative during the Brazilian government audit, carried out at production
Butantan Institute
Sao Paulo / Brasil

Position

Position

Senior consulting for internal and external projects related to all aspects of
Quality within the Pharmaceutical Industry (QMS, Validation, Laboratory),

such as:

  • Extensive experience with aseptic manufacturing and process automation.
  • Labware 8 experience and project management with customers
  • Master Data Management harmonization and definition support.
  • Different Computerized System Validation projects based on GAMP5.
  • Audit Readiness Project expert for customers.
  • Project Management and implementation of e-QMS (ex: SoftExpert and ZenQMS).
  • Harmonization and/or improvement of Quality SOPs.
  • Coordination of all measures and activities to improve the QMS and control of implementation activities.
  • Creation and implementation of QMS specific manuals and training concept with System Owner.
  • Planning, introduction, implementation and monitoring of procedures and processes for quality assurance.
  • Non-conformance and CAPA management.
  • Support in the GAMP5 validation of the e-QMS.
  • Planning, implementation, and monitoring of release tests for new services and products.
  • Participation in the creation and release of technical documentation.
  • Risk Assessment based on FMEA.
  • Technical support involving the validation activities related to the global Labware 8 LIMS application.
  • Master Data Migration Management and creation of Test Plans related to Master Data testing.
  • Supporting laboratories in process harmonization and compliance
  • Management of Test Plans within the ALM system, involving the upload of the plans and the approval flow.
  • Supporting all validation activities related to the global Labware 8 LIMS application.
  • Execution of comprehensive CSV GAP Assessments for systems such as Empower, Labware 8, COMOS, CMX and others.
  • FDA Audit Readiness compliance checks and preparation support.
  • Compliant setup of MES and SAP interfaces, including field mapping and Master Data Harmonization
  • FDA Audit Readiness project member and compliance consultant
  • Creation Review of CSV related validation documentation such as Test
  • Plans, Configuration Specification, Release Validation Plans and more.
  • Creation of a robust Validation strategy, considering the reality of the customer.
  • Validation strategy alignment with local and global stakeholders.

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