You will be responsible for performing batch record review (checking the production process based on documentation) within the SPP manufacturing units DS and DP from the production perspective so that products and processes within SPP are carried out correctly and according to guidelines and laws and regulations. You will identify deviations and changes and, if possible, handles these independently or switches to those responsible within manufacturing and ensures that the production employees involved are informed and implements improvement initiatives in such a way that deviations are minimized.
- assesses the completeness and correctness of production documentation for the production department, identifies deviations, assesses these and ensures the recording of additional relevant information or switches (depending on the deviation) to the Quality Engineer, SMEs or QA;
- investigates deviations and identifies opportunities for improvement, including adjusting the template for batch review and/or giving feedback to production employees;
- reports or (frequently) identified deviations to the relevant manager and, if necessary, coordinates with other departments about opportunities for improvement;
- transfers knowledge about batch record review to involved production employees;
- gives instructions to employees about changed and new regulations and templates for batch review and guides them in their introduction and application;
- HBO education in the field;
- several years of experience as an operator in the production of pharmaceuticals;
- knowledge of current legislation and regulations, quality systems, guidelines and procedures;
- both written and oral expression skills in Dutch and English are required for the various internal and external contacts.
Interested or know someone? Send your CV to Beata at firstname.lastname@example.org or get in touch at 020 2044 502