Guy Lechien Email & Phone Number

Europe

Provide support to the lifesciences & chemical businesses, by:- Helping manufacturing sites to be inspection ready (GxP)- Performing GXP audits on behalf of clients in the pharma sector- Leading projects (PM, PMO or CM)- Coaching/mentoring team members to increase their quality mindset- Supporting leadership teams in their deployment of new strategies.....Focus on cGMPInternational coverage

Région De Bruxelles, Belgique

As Consulting Manager I have two areas of focusFor the client: • Raising the cGMP understanding at all levels of the MPU • Encouraging new behaviors in front of quality issues • Supporting the management of deviations and CAPAs • Ensuring inspection readiness for the teams and support them during internal and external auditsFor Avertim: • Supporting new client identification • Managing internal initiatives upon request • Coaching junior consultants

Mission In Gsk Biologicals

The goal of the current mission is to support a multidisciplinary team in order to increase their efficiency.The mentoring activities are focussed on:1/ Identifying gaps between strategies and results2/ Shadowing key team members to understand where to concentrate efforts3/ Facilitate team workshops focussed on process improvement4/ Daily follow-up QA and production activities/relationship5/ Put in place systems to ensure that efficiency increase is sustainable

Europe

As a consultant, I'm a key partner in the field of Quality Assurance and project management.My mission will always be to satisfy my customers in a win-win relation.My goals are to share with customers my experiences and competencies to meet their business challenges in the following areas (non-exhaustive list):* Auditing (API, chemicals, Finished products, services, warehouses,...)* Support to be prepared before being audited (Inspection readiness - pre-audits)* Quality systems setup, deployment and improvement* Business development ( QA due diligence)* Project management (PM & PMO)* Change management (ADKAR certified)* Event preparation* Training/coaching (Pharmaceutical regulation, Quality systems, GxP, time management, project management,...)* Support to leadership team and key new managers when unleashing their potential.Aside to all these Lifesciences & Chemical activities, I'm also managing private B&B renting solutions in Belgium and in France, I'm co-leading an airfield business activity (events linked to flying area and teambuildings proposals).

As a consultant, I'm a key partner in the field of Quality Assurance and project management.My mission will always be to satisfy my customers in a win-win relation.My goals are to share with customers my experiences and competencies to meet their business challenges in the following areas (non-exhaustive list):* Auditing (API, chemicals, Finished products, services, warehouses,...)* Support to be prepared before being audited (pre-audits)* Quality systems setup, deployment and improvement* Business development ( QA due diligence)* Project management* Event preparation* Training/coaching (Pharmaceutical regulation, Quality systems, GxP, time management, project management,...)

Act as a Third-party auditor for quality audits in the pharmaceutical environment (APIs, Excipients, medical devices, finished products, services, CMOs,...)

GxP Business Analyst* Deployment and management of an eDMS (FirstDoc) system for GxP documentation management.* Key contact person for business related issues with regard to global implementation of GXP documentation standards;* Lead the establishment and improvement of all our process standards for Documentation Systems;* Lead the simplification and harmonization of corporate and global processes with regard to controlled documents within UCB together with the relevant business partners;* Manage lifecycle of corporate controlled documents, global QA controlled documents and other global and local controlled documents in agreement with relevant management.

Work as manager of Third-Party Finished Goods suppliers for Region EuropeAcquired experience: * Approval (audit) and maintenance of Baxter approved suppliers against ISO and MDD guidelines. * Development of quality agreements with suppliers. * Perform due diligence, on-cause audit, SCAR management... * Ensure Third-party supplier compliance with the revised Medical Device Directive * Be the supplier quality contact point and liaison for all european local QA working in warehouse and distribution area.

Work as manager of Third-Party Raw Material suppliers (API, Excipients) to support Region EuropeAcquired experience: * Approval (audit) and maintenance of Baxter approved suppliers against GMP for API and ISO 9001 guidelines. * Development of quality agreements with suppliers. * Due diligence, on-cause audit,... * Setup and deploy in Europe Baxter Supplier Quality system. * Support the manufacturing QA and the Regulatory team in CTD modules 3.2.S preparation. * Baxter Europe representative in the APIC * European SQA contact with the Global Compliance Services

Manage, support and coordinate development of premis solutions.Acquired experience: * Technical expertise in the field of Drug Delivery by participating in multifunctional / multi-disciplinary project teams in the evaluation, selection and adaptation of various engineering and/or research techniques. * Make recommendations, identify hurdles and potential improvements. * Plan and coordinate feasibility studies as well as transfer to the manufacturing. * Work as a project manager for the development of global productsCo-author of “Stability of drug additives in Peritoneal Dialysis solutions in a new container “M. Voges, D. Faict, G. Lechien, M. Taminne (Peritoneal Dialysis International, Vomule24, Number 6, 2004)

Baxter R&D Europe in the Pharmaceutical Development department.Work as laboratory specialist for the study of drug compatibility and stability in flexible containersAcquired experience: * HPLC analytical method development and qualification. * Analysis of defectives medical devices returned from customers. * Development and implementation of stability studies for drugs products.

Dow Corning, Personal Care group, Woluwe.Work as chemist for the development of new silica-based emulsifier used in cosmetics.Acquired experience: * Knowledge of cosmetology (cream, emulsifier, stability) * Surface tension determination (ring, plate mth.) * Development of Interfacial tension determination method using spinning drop technique. * Development of NIR technique for Silica analysis

Master, Chemical Engineering

Production Management Assisted By Computer (Gpao)

Change Management Practioner, Adkar Methodology By Prosci, Certification On Changement