Marcel Bos Email & Phone Number

Bilthoven

QA Project supportReview of qualification and validation documentationRepresenting QA in risk assessments, root cause analysis, change and deviation handlingAdvising production and technical departments regarding validation guidelines and methodoligies.

Uden

Development of a Quality System based on international standards (ISO 9001:2015 / ISO 17025:2018).Introduction of Tier methodology, provide training in GMP-aspects.Advise management in follow up steps to improve overall quality

Uden, The Netherlands

Freelance (ZZP) Consultant. Specialized in Project QA support during procurement, qualification and validation of pharmaceutical (processing) equipment, utilities and premises.

Oss

Performing cross-contamination risk analysis for producing highly active products in small scale multi-product facility (sterile).

Uden

Perform GAP Analysis to ISO 17025:2018 of actual quality system (ISO 9001:2015 based).Advise management for follow-up steps

Nijmegen En Omgeving, Nederland

Working on:Change Management system updateValidation Master Plan updateImprovement data integrity in SAP logistic management system

Bilthoven, The Netherlands

Change control backlog remediation, development and training of improved change control procedure. Consulting on methods for improving communication between departments and management Introduction and training in Tier method for improvement of communication and ownership.

Oss, The Netherlands

Review and approval of pre-qualification documentation as part of the preparations for the start of Bioconnection Operations in 2016.

MSD, Oss, The Netherlands

- Review and approval of Qualification and Validation documentation ( URS, FAT, SAT, IQ/OQ/PQ)- Specialized in Sterile Production, Subject Matter Expert for Merck World-wide Sterile Standards- Expert in Change and Deviation Management- Specialist and trainer of Change and Deviation Management System (TRACKWISE)- Subject Matter Expert Mediafill (e.g..

Oss, The Netherlands

Safeguarding of the GMP Compliance within Commercialization Operations - Oss (production of clinical phase III and IV medication)Review and approval of Qualification and Validation documentation of production and analytical equipment Deputy Sectionleader Quality Systems department of Research & Commercialization Quality (RCQ) - OssRepresenting RCQ - Oss in.

Oss, The Netherlands

Leading Facility Management group of Product Development OrganizationSelection, purchase and qualification of production equipmentPreparation of User requirements and test protocols voor equipment Control of validation status of equipment, areas and utilitiesManagement of production equipment and utilities

Oss, The Netherlands

Project Coordination (technical) for oversees production locations of NV Organon. Countries involved a.o:Ireland, Brasil, Bangladesh, India, China, South-Korea and Mexico. Defining User Requirements Specifications, Selection of Supplier, Inspection during construction, Commissioning of major production equipment for the pharmaceutical industry.

Groot-Ammers, The Netherlands

Responsible for obtaining ISO 9001certification at location Groot-Ammers

Groot-Ammers, The Netherlands

Various functions within research:Group leader Production Support Laboratory (1990 - 1992)Groupleader Analytical Laboratory (1986 - 1990)Analyst at Analytical LaboratoryInstrumenteel analist (1985 - 1986)Research laborant industrial finishing (1980 – 1985)

Aarle-Rixtel, The Netherlands

Performing color analysis of produced materials

Ing. (Equivalent To Bsc), Chemistry

Study outside working hours

Post-Hbo, Total Quality Management

Post Academic Study on Total Quality Management, based on ISO 9001.

Lean Six Sigma Green Belt, Quality Management, Score 82%

Internal Auditing, Iso9001

Lead Auditor Iso 9001:2008, Score: 82,5 %

Training for Lead Auditor ISO 9001:2008 with the aim to become Certified Lead auditor. Consists of 5 days intensive training on all.

Basistraining Creatief Denken Cocd, Certificaat

Training in creative methods for out of the box thinking.