Director Comm. QA Compliance EU/EEA & Qualified Person Incyte Biosciences Distribution Member Global Incyte QA team
The Randstad, Netherlands
Owner @ Owner, coach From September 2011 to Present (4 years 2 months) AmersfoortHead Quality Assurance / Qualified Person & member Management Team @ Main responsibilities • Contribute to defined company goals and targets • Responsible for Quality Assurance with all aspect of Quality Assurance • Leading and coaching the Quality Assurance Department Main achievements • Defined...
Owner @ Owner, coach From September 2011 to Present (4 years 2 months) AmersfoortHead Quality Assurance / Qualified Person & member Management Team @ Main responsibilities • Contribute to defined company goals and targets • Responsible for Quality Assurance with all aspect of Quality Assurance • Leading and coaching the Quality Assurance Department Main achievements • Defined and implemented Quality System (Improvement) Plan • Build a solid team within the Quality Assurance Department • Oversee all action related to Quality (GMP/GDP) From January 2007 to Present (8 years 10 months) Manager Third Party Quality Assurance / Qualified Person @ Main responsibilities • Third party quality evaluation • GMP audits at toll manufacturers • GDP audits at affiliates • Technical agreement management • Pharmaceutical product maintenance • Qualified person Main achievements • Initiating and starting with implementing a strategy for quality assurance of in-licensed products marketed by affiliates of Astellas. From April 2006 to December 2006 (9 months) Head Quality Assurance / Qualified Person @ Main responsibilities • Auditing pharmaceutical manufacturing plants and laboratories • Responsible for the prequalification of the manufacturing plant Svizera Labs Private Limited (India) at the WHO • Monitoring the quality and release for market of pharmaceuticalsand medical sterile devices • Responsible for the prequalification process of pharmaceutical products at WHO • Registration of pharmaceuticals in middle- and low-income countries • Contact person to national and international drug authorities as well as to customers like the Global Drug Facility, World Health Organization Main achievement • Upgrade the GMP level of Svizera Labs Private Limited to international (EU) GMP standards, resulting in WHO prequalification approval (EU standard). From February 2004 to March 2006 (2 years 2 months) Quality Assurance Manager / Qualified Person & member Management Team @ Main responsibilities • Auditing pharmaceutical manufacturing plants and laboratories • Monitoring the quality and release for market of pharmaceuticals and medical sterile devices • Quality manager (ISO 9001-2000) – initiating, implementing, approval and monitoring of the quality system • Registration of pharmaceuticals in middle- and low-income countries • Educate employees of different departments related to pharmaceuticals Main achievements • Initiating, implementing, approval and monitoring of GDP • Initiating, implementing, approval and monitoring of ISO 9001-2000 • Upgrade the GMP level of Svizera Labs Private Limited (India) to international (EU) GMP standards. • Development of the so called “Tuberculosis Patient Treatment Kit” From January 1999 to January 2004 (5 years 1 month) Hospital Pharmacist @ Main responsibilities • Managing drug supply • Leading a team of 10 people • Support the manufacturing of non-sterile and sterile medicines, Main achievements Besides running the hospital pharmacy, the introduction of two working documents with reference to hospital manufacturing in the hospital of Aruba From July 1997 to September 1998 (1 year 3 months) WinschotenMaster of Science, Pharmacy @ University of Groningen From 1992 to 1997 Quality (GMP) and management related @ Novartis From 2007 to 2012 NLP Coach @ NTI-NLP From 2009 to 2012 GMP related @ David Begg Associates - UK From 1999 to 2009 Bachelor of Science, Laboratory - Biochemistry @ Rijks Hogeschool Groningen From 1987 to 1992 ChiTree Trix Tuin is skilled in: GMP, Pharmaceutical Industry, Regulatory Affairs, CAPA, Validation, Quality System, Change Control, GxP, FDA, Quality Assurance, Quality Auditing, Coaching, Team Building, Coaching Staff, Project Management, 1 op 1 coaching, Communication, Leadership, Risk Management, Risk Assessment, Regulatory Requirements, Personal Development, V&V, Sop, Generic Programming, Technology Transfer
StapIn-Coaching
Owner
September 2011 to Present
Amersfoort
Sandoz BV (a Novartis Company)
Head Quality Assurance / Qualified Person & member Management Team
January 2007 to Present
Astellas Pharma
Manager Third Party Quality Assurance / Qualified Person
April 2006 to December 2006
Svizera Europe BV
Head Quality Assurance / Qualified Person
February 2004 to March 2006
The Medical Export Group BV
Quality Assurance Manager / Qualified Person & member Management Team
January 1999 to January 2004
Dr. Horacio E. Oduber Hospital at the Dutch Caribbean Island Aruba
Hospital Pharmacist
July 1997 to September 1998
Winschoten
University of Groningen
Master of Science Pharmacy
1992 to 1997
Novartis
Quality (GMP) and management related
2007 to 2012
NTI-NLP
NLP Coach
2009 to 2012
David Begg Associates - UK
GMP related
1999 to 2009
Rijks Hogeschool Groningen
Bachelor of Science Laboratory - Biochemistry
1987 to 1992
ChiTree
What company does Trix Tuin work for?
Trix Tuin works for StapIn-Coaching
What is Trix Tuin's role at StapIn-Coaching?
Trix Tuin is Owner
What industry does Trix Tuin work in?
Trix Tuin works in the Pharmaceuticals industry.
Who are Trix Tuin's colleagues?
Trix Tuin's colleagues are Leandro Nery, Itamar Figueredo, Camilla Gjermansen, Jane Sefort Tidemand, Karsten Haumann, Jeanette Jonesco, Karin Maria Andersson, Tina Hornum, Søren Dierks, and Paivastoon Sayed
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