Quality Specialist

Professional Qualifications • HBO-A Analytical Chemistry
• High School Industrial Chemistry
Training • Continuous internal training to comply with the specific tasks on hand (Artwork reviewer, BOM reviewer and Complaint assessor)
• Continuous internal training to comply with GMP requirements
• Good Manufacturing / Laboratory Practice (GMP/GLP)
• Applied General Statistics, internally given
• Good Documentation Practice (GDP), internally given
• On the job training Document management system administrator
• On the job training Validation of computer applications
Summary of Experience
• Over twenty years’ experience working in the pharma diagnostics industry.
• Strong technical and general management skills with ability to focus on critical aspects of the jobs and offer worthwhile professional judgement.
• As a Quality Manager, has an awareness of the regulatory requirements and international standards, has created procedures and managed and maintained qualification systems for Quality and site manufacturing groups.
• Experience with the GxP rules and the values as set in the ISO 9000 and 9001 Quality Management Standard, ISO13485 2003 Medical Device Quality Standard, cGMP and GLP guidelines and the 21 CFR Part 820/821 Quality System Regulation.
• Experience with complaint handling process, change control and CAPA’s.
• Excellent communication, project management and analytical skills. Can work effectively on own initiative and as part of a team.


Project Experience
- MSD, Oss, The Netherlands
QA Officer
- Team member IT remediation activities
- General assistance for all QA activities

• Amgen B.V., Breda, The Netherlands
QA Specialist BOM Reviewer responsible for:-
− Participation in improvement projects in regards to the BOM review and approval process.
− Maintaining contact with Sales, Registration, Complaints, warehouse and production departments in regards to the BOMs.
− Checking content of BOMs (Bill of Materials) also regarding the correctness for jurisdiction control and other references, using the specific quality systems (Trackwise) set in place for this.

• Intervet B.V., Boxmeer, The Netherlands
Detailed Application Verification team member responsible for:
− Providing inter-site support and direction necessary to meet the timelines of the Global DAV project.
− Translation of Global DAV objectives and expectations to sites.
− Translation of Site concerns to Global DAV project team.
− Serving as a source for the site contact in event of resource constraints needed to meet commitments.

Stability Development Project team member responsible for:
− Analysis and standardization of Master Stability source data.
− Analysis and development of General Stability protocols at product level.
− Analysis and development of a trend analysis for On-Going Stability data.
− Serving as a source for the project team in event of resource constraints needed to meet project commitments

• Amgen B.V., Breda, The Netherlands
QA Specialist Artwork Reviewer responsible for:
− Checking content of artwork against approved text, change record and other references, using the specific systems set in place for this.
− Maintaining contact with Registration, Complaints, warehouse and production departments in regards to artwork.
− Participate and lead improvement projects in regards to artwork and the artwork review process.

QA Specialist Complaints Assessor responsible for:-
− Checking returned sample(s) and reporting on findings in regards to registered complaint.
− Maintaining contact with Registration, Complaints, warehouse and production departments in regards to complaint sample/lot.
− Participate and lead improvement projects concerning the complaint handling process.

• bioMérieux B.V., Boxtel, The Netherlands
Quality Manager:
− Overseeing the production process, drawing up an achievable production schedule.
− Organize and train the use of different laboratory automation systems within the quality departments. (SQL*LIMS).
− Organize and administrate the competences of all quality employees in the training management system.
− Responsible for the release of finished products.
− Helpdesk for all applications in use within the production & quality departments
− Organize, manage and administrate all activities needed for Certificates of Analysis, including design, management and production.
− Organize, manage and administrate all paper batch files under responsibility of the quality departments.
− Organize, manage and administrate all training and use of the ERP system within quality control (Movex).
− Organize, manage and maintain the sample archive system.
− Initiate and participate in improvement projects concerning quality systems within the organisation.
− Organize the transfer of the different Quality systems to the other bioMérieux locations.
− Organize and aggregate transfer files for re-registration purposes for third-party products (OEM).
− Organize, manage and maintain the Deviations Quality System.

Quality Control Registration Assistant & Application Manager:
− ERP for Quality Control.
− Maintenance of the Lab Information Management System (LIMS).
− Document Management administrator.
− Management and maintenance of the Archive Sample database.
− Batch History Files archive.
− Administration and initiate system use.
− Create and implement CoA use.
− Administrate Deviations process.

• Organon Teknika B.V., Boxtel, The Netherlands
Application Manager / Head Services Quality Assurance / Complaint Co-ordinator:-
− Various Quality roles over several years’ experience with Organon Teknika from dealing with customer complaints through to management of the Quality Managements Systems.
− Dealing with ISO Standards, 21 CFR’s and European standards and cGMP guidelines.

Group Leader Services / Laboratory Assistant / Sampler (Oss)
− Various roles for equipment calibration, validation, maintenance, qualification and general QC training

1972 tot 2001
Akzo Nobel, Organon, Organon Teknika in Oss
Analist, groep leider, applicatie manager

2001 tot 2010
Biomeriuex, Boxtel groep leider en assistent manager QC labs

2010 tot 2014
Scitech BV, QA Specialist consultant Breda, Boxmeer, Breda