The Quality Assurance Associate is responsible for maintaining the compliance status within the Quality assurance department with a main focus on the document control quality system and raw material specification system.
- Document Control specialist which is responsible for maintaining and improving the document management system within the site Tilburg.
- Setup and maintain raw material specifications to comply to the appropriate food and pharmaceutical regulations, respectively HACCP and GMP requirements, using R&D data, EP/USP monographs, CEP’s and any further additional information required for the Raw material specification.
- Research raw material information and compile the information into various statements (allergen, BSE etc.) for various customers.
- Support in maintaining and improving the vendor management system.
- Setup and maintain vendor quality agreements.
- Contribute to the design of EU compliant policies.
- Develop and maintain policies, standards and systems; initiate corrective actions if regulations change.
- Align local processes and systems with the approved policies.
- Execute the Quality management systems according to the corresponding and approved policy.
- Evaluate the performance of systems and processes.
- Initiate corrective or preventive actions if there are system or process defects.
- Actively seek for and absorb new information with reference to the functional area.
- Communicate new information to colleague.
- Implement new information in practice.
- At least 2 years relevant experience in the pharmaceutical- and/or food industry.
- Knowledge of pharmaceutical and food guidelines as mentioned above.
- Experience with software, under which Word, Excel and PowerPoint.
- Communication Skills: Fluent in Dutch and English (understanding and writing).
- Able to interpret guidelines and pharmacopeia for possible impact on products and/or other site related topics.