Non-Conformity Management | Audit Execution & Management | CAPA Management | Batch Release

Quality Management System | Procedure Design | Root Cause Analysis | Risk Analysis | Training

Validation-Qualification | Aseptic Environment Management | Team Management

Interaction with Authorities, Clients, Subcontractors, & Suppliers | Verse | QAAD | Trackwise

UMONS, Charleroi, Belgium

Complementary Master’s degree in Total Quality Management, with honors                                                                    2015

Final thesis on human reliability (risk analysis)

Inter-Universities Program:

Université Catholique de Louvain (UCL), Brussels, Belgium

Université Libre de Bruxelles (ULB), Brussels, Belgium

Université of Liège (ULg), Liège, Belgium

Complementary Master’s degree in Pharmaceutical Industry, with distinction                                                                  2010

Université Catholique de Louvain (UCL), Brussels, Belgium 

Master’s degree in Pharmaceutical Sciences, with one distinction and one satisfaction                                                  2009

Université de Namur (FUNDP), Namur, Belgium

Bachelor’s degree in Pharmaceutical Sciences, with two distinctions and one satisfaction                                             2007

QPPV Certification, Belgian Health Authorities (AFMPS), Brussels, Belgium                                                                 2012

QP Certification, AFMPS, Brussels, Belgium                                                                                                                           2011

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Professional Development:

Assertiveness: Ability to Assert and Persuade, Co-valent, Nivelles, Belgium                                                                     2015

Qualified Person Education Course, QP Association, Munich, Germany                                                                           2015

PDA Cell Therapy congress, Florence, Italy                                                                                                                              2013

Dutch Language Classes, C.V.O., Brussels, Belgium                                                                                                    2012, 2011

XEVMPD Training, EMA, Brussels, Belgium                                                                                                                              2011

EudraVigilance User Training, EMA, London, UK                                                                                                                     2011

R&D Internship, TetraQ, Brisbane, Australia                                                                                                                            2010

Pharmacy Internship, Pharmacie de l’Escadron, Brussels, Belgium                                                                                     2009

Pharmacy Internship, Pharmacie Balza, Villers-la-Ville, Belgium                                                                                        2008

• Conduct and follow up on internal and external pharmacovigilance audits;

• Manage and track corrective and preventive actions (CAPAs) with auditees;

• Provide training to UCB operational teams on root cause analysis and coach auditees on defining proper CAPAs and adequate evidence for closure;

• Review of pharmacovigilance-related procedures;

• Develop a Pharmacovigilance Business Continuity Plan across Affiliates;

• PVQA SME while transitioning to a new audit management software (process design, data migration, software validation);

• PVQA SME for a Robotic Process Automation project (robot validation);

• Received positive feedback from Manager and colleagues for adding value to the team and providing relevant remarks and clear explanations while quickly adapting to another regulatory environment (GPvP).

​Quality Assurance:

• Worked with three-person team to create Quality Management System (QMS) from inception and implemented/managed the subsequent life cycle of documents:

• Wrote, evaluated, and approved QMS procedures; reviewed team’s work and provided final approval of documents;

• Presented and defended QMS during eight audits by clients and four inspections by Belgian Health Authorities to ensure compliance of quality system and drug products with EU Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP);

• Conducted internal/external qualification and follow-up audits of internal processes, suppliers, and subcontractors’ systems;

• Reviewed batch records and released Biotechnological Investigational Medicinal Products (IMPs), including non-EU batches;

• Involved in the launch of four new IMPs used for clinical trials and/or compassionate uses (reviewing Investigational Medicinal Product Dossier (IMPD) prior submission to Authorities, ensuring compliance of master batch records, QC methods, raw/starting materials-, consumables- and Drug Product specifications, Drug Product- label template, packaging and storage conditions to IMPD, reviewing specific protocols for reproducibility batches, aseptic processes simulations, equipment and production operators qualifications, QC methods-, Drug Product stability-, packaging- and shipping validation, auditing and selecting involved suppliers and subcontractors, assessing any risk or change in project-related processes, following projects with clients, training and coaching dedicated QA team members, reviewing non conformities, implementing CAPAs and defending the quality management system during Competent Authorities’ pre-launch inspection);

• Approved validation/qualification protocols and reports for equipment, media fill tests, material integrity, reproducibility batches, material inlet, cleaning, gowning, quality control (QC) methods, shipping, HVAC, and environmental monitoring;

• Assessed quality-related training for QA team members and approved quality agreements with subcontractors, suppliers, and clients;

• Complied with IMPD when approving specifications, master batch records, and drug product labels;

• Analyzed risks while reviewing non-conformities, change control requests, practical challenges, and production process design in order to foresee issues and implement adequate CAPAs;

• Handled nonconformities by investigating impact and root cause, analyzing risks, and correcting the issue; defined and followed up on adequate CAPAs and related closure criteria;

• Authorized changes through change control process to QMS, raw materials, consumables, operational processes and organization, design of facilities, equipment location in clean rooms, replacement of equipment, temporary derogation to a procedure;

• Organized QA-RA group with representatives from eight companies to share regulatory updates, challenges, and experiences. Group invited by the Belgian Health Authorities to provide feedback on a new GMP guidelines project;

• Qualified to work in aseptic conditions (Grade A gowning qualification);

• Earned qualification to serve as Lead Auditor, auditing internal processes and suppliers’/subcontractors’ quality systems;

• Met all deadlines in a high-stress environment due to patients’ life-threatening diseases and short time constraint

Regulatory Affairs:

• Reviewed clients’ IMPDs to ensure compliance with European standards/operational practices and provide tips on strategic writing;

• Drafted clinical trial protocol to obtain human body material supply in order to train production operators on cell culture;

• Submitted demands and declarations to the Ministry of Health according to national requirements;

• Performed Regulatory Vigilance for GMP/GDP activities: follow-ups with industry groups’ newsletters, authorities’ updates, continuous training, and networking;

• Prepared customs documents for animal derived-products imported from outside EU.

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Team Leadership:

• Supervised, coached, and inspired a four-member team, familiarizing two members with GMP/GDP and leading by example. Defined training plans and developed team’s competencies;

• Led weekly team meetings, interviewed candidates, evaluated employee performance, and promoted two team members;

• Delivered basic GMP training for new hires and trained employees seeking qualified auditor roles.

Regulatory Affairs:

• Prepared variation dossiers for new Drug Products to internalise (acquisitions);

• Verified Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) content;

• Translated PIL content into English and formatted according to Quality Review of Documents (QRD) template. Designed PIL readability tests;

• Created common technical document (CTD) file (bibliographic modules four and five).

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Pharmacovigilance:

• Reviewed the Detailed Description of the Pharmacovigilance System (DDPS) and related procedures to comply with EU regulation;

• Researched and reported on adverse events weekly; prepared and reviewed complete Periodic Safety Update Reports (PSURs) before submitting to QPPV on duty;

• Assessed risk of the drug products portfolio and developed risk management plan to define the literature search strategy.

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Quality Assurance:

• Performed annual internal audits of QC, Warehouse, and Production departments;

• Conducted on-site packaging inspections daily;

• Reviewed batch records for sterile and non-sterile marketed Drug Products;

• Designated as back-up QP after attaining certification.

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Production:

Assisted as Production Manager back-up for production planning and to ensure correct order of primary containers (ampules).