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Didier : Senior Quality Professional
1580 € HT par jour
Disponibilité : Maintenant {[{ (freelance.date_available <= now() ? 'Maintenant' : freelance.date_available|date:'dd/MM/yyyy') }]} Maintenant préavis de {[{ freelance.preavis }]} mois {[{ freelance.availability }]}
Disponible en part-time: Non

Profil mis à jour le : 03/03/2020

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Didier

55 ans

Berne

Senior Quality Professional Didier

Expériences professionnelles

 

Merck Biopharma - Aubonne, Switzerland
QA Process Manager

Juil 2019 - Jan 2020

Project description

  • Sky project (165 million Swiss Francs investment). Construction of a new facility at existing Aubonne site to increase the production capacity as of 2023.

Position & key responsibilities

  • Issuance, review and approval of GMP documentation (Quality Risk Assessment, Qualification & Validation Protocols and Reports, URS, Specifications, Quality Agreement, Deviations, Change Control, CAPA, VMP, VP and SOPs
  • Quality referent for Equipment Process Project
  • Ensuring compliance and adherence to Merck’ standards, Quality Manual,registration files and regulatory requirements

Merck Biopharma - Aubonne, Switzerland
Process Equipment – Project Manager

Avr 2019 - Juil 2019

Position & key responsibilities

  • Review and assessment of Vendor documentation (technical & engineering specifications, layouts, drawings, I/O list, P&ID, sheets, Commissioning/FAT/SAT documentation and qualification testing matrix, ....
  • Issuance / Creation of technical documentation, URS, QRA, specifications, ...
  • Responsible of suppliers' selection, project deliverables, project schedule and costing
  • Coordination of all activities project‐related (DR/DQ, Commissioning FAT/SAT, IQ/OQ/PQ activities); key contact point and interface between suppliers and internal departments

MSD Animal Health - Igoville, France
Site Quality Director

Jan 2018 - Avr 2019

Project description

  • Transition Manager

Position & key responsibilities

  • Responsible of departmental management (Quality Compliance & System, Quality Control and Operational Quality Assurance): staff of 45 people incl. three direct reports
  • Providing direction and guidance to the Quality & Compliance teams according to GMP standards (FDA, Eur. Ph, Eur. Ph‐like, ANVISA, CFDA, …
  • Acting as central and decision point for all Quality Matters
  • Ensuring Standards application (GMP, GLP, GDP, ICH, ...), and adherence to Company Health and Safety Policies and Regulatory Compliance
  • Reviewing and approving Technical and Quality Agreements
  • Ensuring site inspection readiness CFR 21 211&212, 610, 820, Eudralex Vol 4, WHO
  • Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events
  • Ensuring overall Quality Department KPIs (quality dashboards and performance metrics) in line with business objectives
  • Managing, motivating, coaching and mentoring direct or indirect reports
  • Working with all levels of local organization to maintain and develop the quality mindset
  • Working closely with the site leadership teams to maintain a strong quality culture (highest standards of compliance and lowest risks to patients and customers)
  • Participating in staff and management meetings

ALK- ABELLO - Vandeuil, France
Project Leader & Senior Quality Operational Support

Nov 2017 - Fév 2018

Position & key responsibilities

  • Quality Oversight on revamping project of classified manufacturing areas
  • Review and advice on design & update of lay‐out & plans, technical/user specifications, improvement of existing equipment's
  • Selection of Equipment suppliers and sub-contractors
  • Review and approval of technical and quality documentation
  • Coordinate all testing with suppliers and users

Yposkesi / Généthon - Évry, France
Senior Deviations Investigator & Reviewer

Août 2017 - Nov 2017

Position & key responsibilities

  • Deviations back‐log reduction acting as operational investigator and quality reviewer
  • Advices and recommendations in response to GMP gaps and quality issues raised by authorities

LFB Biomédicaments - Lille, France
Deviations, Investigations and CAPA Senior Reviewer

Mai 2017 - Août 2017

Position & key responsibilities

  • Quality Support – Evaluation of investigation and impact strategy, and CAPA implementation
  • Recommendations and advices for deviations handling and practices, and CAPA efficiency
  • GMP consultancy and advice in response to compliance issues and questions raised by authorities

Sanofi-Pasteur MLE - Lyon, France
Senior Quality & Compliance Consultant

Sep 2014 - Oct 2015

Position & key responsibilities

  • Advice & Guidance on cGMP’s compliance & regulatory standards
  • Deviations & CAPA Management ‐ Expertise, Review, Support and Recommendations to Manufacturing and Quality staffs in the frame of cGMP FDA inspection readiness planned in September 2015
  • Involvement in Site and Local Quality Committees – providing expertise and recommendations with regards to hot topics, risks analysis and mitigation actions, and compliance adherence

AllergoPharma Gmbh & Co. KG
Process Expert

Juil 2014 - Sep 2014

(Merck's subsidiary)

Position & key responsibilities

  • Site Manufacturing Assessment ‐ Proposals and recommendations on processes streamlining & flows improvement (QA, QC, production, supply chain)
  • Challenge and identify areas of risks from compliance, regulatory and business perspectives: risk mitigation plans, pragmatic and efficient proposals to minimize the identified risks

GSK Vaccines - Belgium
Aseptic Coach & Mentor

Jan 2014 - Juin 2014

Position & key responsibilities

  • Development & Implementation of Aseptic Mentoring and Coaching Program on the production shop floor
  • Support and challenge of aseptic practices and behavior with key stakeholders of QA and Production staffs
  • Review of process improvements, and commitments implementation through mentoring & coaching sessions
  • Follow up Effectiveness and Performance (KPI, Dashboard, Survey) of mentoring & coaching program in the frame of cGMP FDA inspection readiness.

GSK Vaccines, Belgium - Belgium
Senior GMP Compliance Expert

Avr 2013 - Jan 2014

Position & key responsibilities

  • Advice & guidance about regulatory expectations & standards through meetings, document review and shop floor visits (Gemba walks)
  • Ensure Sterility Assurance Quality Oversight and Compliance
  • Identify & highlight areas of risk as well as of improvements (focus on aseptic processes and ways of working)
  • Challenge of rationale and documentation content and completeness (review of Risk Assessments of Environment Monitoring plan design for all manufacturing units)
  • Verify appropriate CAPA implementation prior closure; Ensure inspection readiness (Coaching of Aseptic Techniques and Behavior)

UCB Pharma, Brussels, Belgium
Associate Director Center of Expertise for Finished Dosage Forms & Medical Devices

Avr 2011 - Mars 2013

Position & key responsibilities

  • Management of Strategic CMOs’ and Suppliers for activities including quality, business and operational aspects coupled with technical and quality expertise support (acted as sterile expert and member of sterile task force)
  • Provide Regulatory Inspection and Audit support to Third Parties and Partners Sites through Global Audit Program :
    • Perform supplier and third‐party manufacturer audits/due diligences ‐ including follow up and close out
    • Supporting in Quality Topics Resolution and Management
    • Supporting in negotiation and execution of technical and quality agreements
    • Support for third‐party manufacture issue resolution and troubleshooting
  • Conduct Project‐Specific and Vendor/Supplier/Third Parties Qualification Audits to assess the quality level & standards and provide subsequent recommendations
  • Support New Business Opportunities through Due Diligence and Pre‐Contract Audits, issuance of reports and evaluation of corrective and preventive actions
  • Leadership/Coordination of Projects at (non‐)sterile CMO sites. Team member of internal projects.
  • Responsible for Technology transfer and Process Validation on intra/inter‐sites or external partners
  • Involvement in CMOs’ selection /phasing out/ exit as well as in potential merging & acquisitions
  • Plans & Recommendations Development for Strategic Decisions and execution of corporate and strategic plans.
  • Elaboration of business cases and risk assessments while minimizing risk and costs

Catalent Pharma Solutions - Brussels, Belgium
Director New Product Introduction and Process Validation

Mai 2007 - Avr 2011

Position & key responsibilities

  • Key Member of the Site Leadership Team, providing valuable input, contribution and efforts for the site approval by regulatory bodies (e.g. FDA approval for Flu vaccines in pre‐filled syringes)
  • Responsible for Process & Product Transfer and Validation (incl. large or small molecules – proteins, mAb, vaccines, …
  • Projects implementation, execution and achievement
  • Product Life Cycle Management
  • Generic and Specific Media fills approach, and cleaning validation
  • Provide support and advice to other departments for quality improvement
  • Responsible for department self‐audits and external audit
  • Actively be part of customer service
  • Responsible of department budget (> 6 M€ ) coupled with monitoring and control of all expenditures, CAPEX and OPEX
  • Extension of Products Portfolio and Business Revenues to effectively contribute to the site growth and P&L while improving the quality level and focusing on Time‐To‐Market
  • Leadership of Customers’ Relationships and effective interface/cross‐functionality with internal departments (capable to operate transversally)
  • Design and Development of Efficient Projects Organization and Maps (formal roadmap and templates to projects management and validation)
  • Talent development, motivation and management of a staff of 9 people in 2011
  • Resolving technical, quality and supply issues, closely working with customers
  • Performed risk assessments, designed improvement programs and implemented new methods, ideas or processes

NextPharma / Laboratoires Thissen - Brussels, Belgium
Senior Project Coordinator / Leader

Juin 2003 - Mai 2007

Position & key responsibilities

  • Development and implementation of new sterile lyophilized & liquid cytostatic & cytotoxic products and activities including coordination, technical and quality support, documentary aspects, issues resolution, capacity planning, budget respect (2.0 M€ in 2007) and compliance adherence
  • Planning and Leadership of Projects from development to industrialization phases through Product Transfer and
  • Process Validation including formulation and/or freeze‐drying cycle set‐up or optimization, technical feasibility, quality discipline, up-scaling, process improvement initiatives and commercial supplies
  • Key contact point and interface between customers and internal departments, specifically with QA and regulatory depts.
  • Management and development of 2 people in 2005-2007

University of Liège - Belgium
R&D Project Leader / University Assistant / Doctorate

Fév 1993 - Mars 2003

Position & key responsibilities

  • R6D Project Leader: « Development, Synthesis and Pharmacology Testing of New Amiloride Derivatives as Selective Inhibitors of Na+/Ca2+ or Na+/H+ exchangers » (partnerships between Therabel Research Industry, ULg - University of Liège, ULB - University of Brussels and FUNDP - University of Namur)
  • Practical Laboratory Courses (Therapeutics/Pharmaceutical Chemistry)

Formation

 

2002     Ulg - Doctorat en Sciences Biomédicales

2005     UCL - Diplôme en engineering pharmaceutique

1989     Ulg - Master en Sciences Chimiques

Langues

 

Français : Bilingue ou langue maternelle

Anglais : Courant

Néerlandais : Moyen