My client, a global Biopharma company are looking for a QA Specialist CSV to join their growing team. This individual will work alongside the CSV and QA teams to ensure that all CSV work done is compliant to regulations.
QA Specialist CSV
- Ensuring the regulatory and internal company requirements and quality standards for the validation of computerized systems as well as ensuring the application of data integrity.
- Ensuring compliance with regulatory and internal guidelines.
- Evaluation of new applications and identification of the corresponding validation requirements.
- Ensure correct application of change control procedures in the area of ??validation activities.
- Ensuring and maintaining the validation status of computerized systems.
- Participation in risk analysis relating to computerized systems.
To be considered you need to have.
- Degree in IT, chemistry / biology or comparable.
- Several years of professional experience in quality assurance in the GMP environment.
- Knowledge of FDA 21 CFR Part 11 and EU GMP Annex 11 as well as the regulations in the field of computer system validation and ensuring data integrity.
- In-depth knowledge of common software platforms such as Trackwise, DMS, SAP.
- Very good knowledge of German and English.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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