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Quality Management Consultant

Work Experience

Employment Experience

2001- present Pharmaceutical QA Senior Consultant -
LP Consult-Namur, Belgium

1999- 2001 Quality Director, QA Manager
FEDERA S.A. - Brussels, Belgium

1997-1999 GMP Inspector
Internal Auditor Bulk Facilities
SmithKline Beecham Biologicals.
Rixensart, Belgium

1995- 1997 Quality Assurance Assistant Manager
GMP Compliance responsible
Validation/Calibration responsible
FEDERA S.A.
Brussels, Belgium

Education

Education

1990-1994 Chemistry Engineer
University of Leuven

1994 Study Project
Synthesise of Ampiciline derivates
“Analyze of Ampiciline and derivates with HPLC-method”

06/1996 ICCE (International Cleanroom Control Engineering)
“Thermal validation workshops” Pharmaceutical and Biotech Industries

10/1997 Millipore Training
“Integrity Testing”

12/1998 Millipore Bioprocess Training
“Dimensioning, Conception and Optimization Tangential Filtration Systems”

12/1999 ISPE “Workshop”
cGMP -“Sterile manufacturing Facilities, new and renovated”

05/2000 The Center for Professional Advancement (CFPA)
“Surviving an FDA Inspection - FDA Inspection Non-US Sites”

Skills

PROJECT RESPONSIBILITIES
·Establishment of a new Quality Assurance Department within a Pharmaceutical Subcontractor Company. My major objectives were the Implementation of QA documentation system and the implementation of a validation and calibration program.

·Project Manager Responsible for designing and developing a computer application (SDB3, MSAccess) for the documentation system, the validation master plan and the environmental in process control of production.

·Participation in a workgroup for fusion of QA auditing team and validation team.
Responsible for developing the training program

·Reengineering of the QA department: changing from a QA organization with 3 persons into a Company QA system involving all departments and supported by a QA team with 8 persons.

·Qualification department reorganization: improvement of calibration and validation programs, support for the sterilization process validation in the development unit.

·Review of the training system.

·Definition of a new procedure for the treatment of all the deviations and development of a database for follow-up of the correctives actions.

·Auditing and reengineering of in-process control on a vials production line for complying with pharmaceutical industry requirements.

·FDA pre-approval Inspection of the company for a Medical Device.

·Part of the Project Team for the building of a new facility as a Quality Assurance Consultant

EXPERIENCE DETAIL
GMP-Compliance
·Trainer/Lecturer Responsible for organizing and executing all basic pharmaceutical training for all company’s departments (production, technicians, QC, ...).
·Conduct in-plant training.
·Conduct Site audits for bulk facilities, filling and packaging units for drugs and medical devices
·write / review of SOPs
·Respond to external inspections ( Belgium Ministry of health, world major pharmaceutical industries…)
·Develop complaint handling systems and procedure

Validation and calibration:
·Develop Validation /Calibration programs and procedure

Facility Production Operations:
·Aseptic filling and packaging of liquids, suspensions, emulsions, and diluents in syringes and vials.(human; veterinary parenteral pharmaceuticals). (Class 100)
·Sterilization of (semi-)finished products (human pharmaceuticals and Medical devices). (Class 10.000 and 100.000)
·Visual inspection - labeling and blistering of syringes and vials
·Packaging of medical devices.

Product Category/Areas of Concentration:
·Vaccines - Drugs (Human/Veterinary)
·Ophthalmology - Drugs; Medical devices

Languages

French : Mother-tongue
Dutch : Mother-tongue
English : Very good Knowledge

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