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Nijmegen, Ge, Nl

Oss, North Brabant, Netherlands

Oss, North Brabant, Netherlands

Nijmegen Area, Netherlands

- Deviation handling/coordination (incl. complaints, root-cause analysis, evaluation of deviations)- Control that production is executed in line with the guidelines.- CAPA handling/coordination- Change Control coordination- Making sure that deviations, CAPAs, changes and audit observations are handled in a timely and correct manner. Creating trend and periodic reports with respect to these quality systems.

Oss, Netherlands

Writing Product Quality Review (PQR) ICH Q7 guidelines. The job also includes an active participation in an improvement project within the Quality Unit of API-BT.

Kesteren

Assessing the content of GMP action steps in response to internal audits and monitoring status. Providing performance reports and make proposals for improving work processes.Collaborating in Lean Manufacturing improvement.

Performing process safety studies. Familiar with Mettler Toledo RC-1, DSC, TGA, Mettler Toledo Multimax.The duties of Senior Development Specialist remained unaltered.

Independently responsible for projects.Participation in multidisciplinary project teams.Early detection and reporting of problems and deviations.

Developing processes and on time delivery of Active Pharmaceutical Ingredients for the first and second phase clinical trials of potential new drugs.Performing organic chemical reactions on a laboratory scale and scale-up in purpose reactors ranging from 5 to 250 L.Performing and interpretation of analysis (HPLC, NMR, TLC, MS). Performing process risk assessments. Writing process safety reports, batch sheets, batch records and transfer documentation. Responsible for correct implementation of GMP and EHS.

Supervising and assisting with Periodical Maintenance. Performing qualification of process equipment. Participate in the functional improvements of the process equipment.

Theoretical and practical implementation of R&D processes in production.

Nijmegen Area, Netherlands

Operational leadership to process operators.Training and coaching of new employees.Ensuring the production progress and the quality.

Tuzla (Bosnia&Herzegowina)

Analysis of raw materials and finished products.

Bachelor'S Degree, Kwaliteit- En Verandermanagement

Project Management

Education record

Chemical Technology