Description
Responsibilities:Together with other Specialists you will be responsible for initiating and implementing quality improvements.
- You will advise on pharmaceutical technical issues, diagnose problems and provide implementation solutions, as well as advise the IPT Leader Specialties and QR Coach Specialties about the effect on the quality of the product due to changes and / or deviations in the process.
- Evaluate the consequences of external guidelines, as well as initiate and develop pharmaceutical policies and procedures. Assess deviations from procedures and policies and authorising GMP documentation.
- Advise regarding internal and external GMP inspections.
- Head and / or make substantive contributions to research in the case of non-standard, complex or high-impact quality issues, based on your expertise and pharmaceutical analyses.
- Perform Validation studies including cleaning validation.
- Formulate Proposals / business cases for quality improvement projects including deliverables and planning.
- Setting strategy related to validation, drafting protocols and help executing it.
- Creation of annual product reviews as required by EU legislation.
Job requirements:
- Academically qualified preferably in the pharmaceutical direction;
- Ten years experience in a pharmaceutical environment;
- Knowledge of and experience with pharmaceutical technical aspects, GMP processes and packaging technology;
- Independent, decisive, critical and accurate;
- Flexible, honest and a team player;
- Excellent communication and interpersonal skills;
- Excellent English spoken and written