Edwin Smits Email & Phone Number

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 (small and large molecule products, including medical devices). • Batch Disposition Management.• Deviation Management, including CAPA planning and root cause analysis.• Change Control Management.• Regulatory Support.• Product Quality Complaint Management.• Project Management.• Audit Support.• Annual Product Reviews.

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 and root cause analysis- Change Control Management- Regulatory Support- SOP management- Regulatory Support- Audit Support

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.

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.