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QSHE / KAM Manager / Consultant als sparringspartner

QSHE / KAM Manager / Consultant als sparringspartner

Work Experience

Bij diverse organisaties als adviseur de systemen ISO 9001-13485-14001-22000, MVO etc opgebouwd en geimplementeerd.
somtijds op interim basis somtijds in deeltijd maar altijd als project uitgevoerd. Vervolgtrajecten als opvolging liepen via een consultancy bureau.

Work experience:
01-01-2013 until today:
Havenservice Rozenburg B.V. / BIG Machinery, Rozenburg /Velddriel, Netherlands
Position: QSHE manager.
Renewal of ISO 9001, 14001 and VCA** system, specific for specialized company activities.
Building training programs for VCA and VCH (Harbor companies). Giving advice to customers on safety and quality affairs. Safety advisor dangerous goods. Executing internal audits, guidance during external audits. Draw up management reviews. Visit suppliers for SQAS audits.

01-03-2007 /31- 12-2012 vd Pas Consultancy BV, Uden, Netherlands
Position: Business consultant
General consultancy on Management level in the area’s KPI, efficiency, reliability, building plans, general development, business plans, validation plansetc.
QSHE consultancy:
Set up and managing quality systems: ISO 9001-13485-14000-22000 OHSAS 18001, VCA*/**/petrochemicals, GMP food, GMP/GDP/GLP/GCP pharmaceutics, BRL codes, RI&E's (risk analyses for companies and its employees and validation planning for over 200 different companies throughout the Netherlands.
Safety advisor dangerous goods for Banner pharmacaps Tilburg)
Executing internal audits, guidance during external audits at our customers, draw up management reviews for our customers.
Training of employees from our customers on VCA, safety at roadwork, asbestos recognition, and safety in warehouses.
Take care of business presentations, toolbox, etc.
Executing inspections on the work floor for our customers.

30- 09-2006 – 01-03-2007
Unemployed, sabbatical, looking for new opportunities.

01-12 – 1999 / 30-09-2006 Alloga (Nederland) BV –Veghel, Netherlands (currently part of Alliance Unichem)
Position: Manager Quality, NBD and production, member of the Management Team
activities:
QSHE coordinator:
responsible for all aspects regarding Certificates ISO 9001-13485 including pharmaceutical licenses in the Netherlands, setting up release procedures and documents for production (protocols) in order of the different European and USA guidelines.
Manager Production:
responsible for:
total assembly activities for our medical and pharmaceutical customers: Wartner, Fresenius, SSL healthcare, Mentor Medical systems, Kernpharma, Medimade, from first line packaging until end packaging under the guidelines of GMP/GDP/FDA-21-CFR820.
Control on and re-assembly of returns in special re-labelling and re-packaging, change of information leaflets
Development machine park, development of new and improved more efficient processes , New Business Development, extract extra business at the customers, draw up and negotiate Service Level Agreements.
Course leader / trainer for:
GDP/GMP, Quality, audits, efficiency and performance, oncology products, handling dangerous goods in the warehouse, internal company training warehousing and production.
Qualified Person (delegated responsibility form pharmacist):
Control and release of pharmaceutical products and handling release procedures on returns.
Project manager:
Corporate Performance Management, Key Performance Indicators, efficiency, etc.
Validation Manager:
Temperature and humidity control systems, cool packaging and transport, machine park, IT systems, new machinery etc.

01-05-1999 / 31-12-2001 All Logistics Advice – Heeswijk–Dinther, Netherlands
Position: managing director (my own consultancy company)
Activities:
General Management / Interim Management.
Consultancy for logistic organizations on the area’s QSHE, GDP, GMP, Medical devices.
Validation of systems and machinery.
Process and production improvement programs.

01-07-1993 / 30-09-1999 Holland Districare BV - Oss, Nederland (part of TNT-group)
Position : Manager Quality and production, Member Management Team.

Manager Quality: ISO-9002 certificates, obtaining and establishing all pharmaceutical licenses as required by Dutch government: including the license for production on pharmaceuticals.
Development of cleanroom systems, including engineering guidance during the build of these cleanrooms.
Manager Production: assembly for: B. Braun Medical, Medimade, Mentor Medical Systems, Fresenius, Allergan. Development of new and improved more efficient assembly processes and procedures,
Course leader –trainer GDP/GMP, Quality, audit, production, efficiency, transport of dangerous goods, etc.
Qualified Person: Control and release of pharmaceutical products and handling release procedures on returns. (delegated responsibility form pharmacist)

01-09-1986 / 30-06-1993 Intexo Veghel BV – Veghel, Nederland (currently part of DHL)
Position: Head Data processing.
Development first quality system for (Netherlands and Belgium (Londerzeel).
Development of one of the first ISO 9002 certifications in logistics in the Netherlands and Belgium
Develop internal company training and course leader during this training for 200 employees .
Development and testing new software (AS-400 system.)
Project responsible for own department.
Responsible for system back-up’s etc.
Responsible for the companies set deadlines.

01-09-1980 / 31-08-1986 Dutch Army ( Volunteer)
Position: Sergeant Administrator.
End rank: Sergeant Major.
Activities: army administration.
Secure military law and legislation in the company.
10-01-1979 / 31-08-1980 Dutch Army (duty)
Rank: private: gunner.
01-06-1977 / 10-01-1979 Meubelfabriek De Paal, Schijndel, Netherlands
Aspiring furniture maker.

Education

Courses all on Post HBO:
QSHE Post HB
International internal auditor ISO
law and legislation pharmaceutical products
GDP and GMP (pharmaceuticals)
sterile medical devices
2008 VOL-VCA
2011 safety advisor dangerous goods by road

Skills

Competences:
Strong analytical
Coaching
Pro-active
stress resistant
A bit stubborn
Independent
pragmatic


Languages

Dutch (native)
English (good in word and writing)
German (good in word and sufficient in writing)


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