Edwin Smits
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Edwin Smits Email & Phone Number

Senior Specialist, Product Quality Manager at Organon
Location: Uden, North Brabant, Netherlands 4 work roles
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Current company
Role
Senior Specialist, Product Quality Manager
Location
Uden, North Brabant, Netherlands
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Who is Edwin Smits? Overview

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Edwin Smits is listed as Senior Specialist, Product Quality Manager at Organon, a company with 795 employees, based in Uden, North Brabant, Netherlands. AeroLeads shows a matched LinkedIn profile for Edwin Smits.

Edwin Smits previously worked as Specialist, Stability Quality Control at Msd Netherlands and Lab Coach (interim), Analytical Quality Control at Msd Netherlands.

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Organon

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About Edwin Smits

Edwin Smits is a Senior Specialist, Product Quality Manager at Organon.

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Edwin Smits's current company

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Organon
Organon
Senior Specialist, Product Quality Manager
united states
Website
Employees
795
AeroLeads page
4 roles

Edwin Smits work experience

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Senior Specialist, Product Quality Manager

Current
  • Global role as Product Quality Manager for the External Quality Assurance department, Quality Oversight was provided for Contract Manufacturing Organizations that manufactured aseptic and terminally sterilized products.
  • Batch Disposition Management.
  • Deviation Management, including CAPA planning and root cause analysis.
  • Change Control Management.
  • Regulatory Support.
  • Product Quality Complaint Management.
Oct 2018 - Present

Specialist, Stability Quality Control

Oss, North Brabant, Netherlands

In this role as the Subject Matter Expert responsible for all drug product stability related items for the MSD Oss location the main responsibilities were:- Content driven guidance of stability employees- Stability study coordination (sample and stability chamber management, stability protocols and reports) - Deviation Management, including CAPA planning.

Jul 2012 - Sep 2018

Lab Coach (Interim), Analytical Quality Control

Oss, North Brabant, Netherlands

In this (interim) Lab coach role the main responsibilities were coaching the (analytical) analysts of this group and the approval of analytical results for excipients and bulk materials, including deviation and lab investigations.

May 2011 - Jun 2012

Associate Specialist, Analytical Quality Control

Oss, North Brabant, Netherlands

In this period my role started as analyst performing analytical testing on raw materials (excipients and drug substances) and bulk drug products. During that period the responsibilities changed from analyst, reviewer to an “Approver” role being responsible for approval of analytical results, including deviation and lab investigations.

Jun 2000 - Apr 2011
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FAQ

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What company does Edwin Smits work for?

Edwin Smits works for Organon.

What is Edwin Smits's role at Organon?

Edwin Smits is listed as Senior Specialist, Product Quality Manager at Organon.

Where is Edwin Smits based?

Edwin Smits is based in Uden, North Brabant, Netherlands while working with Organon.

What companies has Edwin Smits worked for?

Edwin Smits has worked for Organon and Msd Netherlands.

Who are Edwin Smits's colleagues at Organon?

Edwin Smits's colleagues at Organon include Megan Chen, Nucharin Chanachitpairee, Ahmed Samir, Raymond Norman, and Bruno Maduenho.

How can I contact Edwin Smits?

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