Description
GMP Qualification and Validation (CSV)(Computer System Validation)
/ Bern/ Biopharmaceutical
General description:
Define the validation strategy for Computerized Systems (CSV), equipment, facilities and utilities.
Perform the validation of new or upgraded production / laboratory computerized systems (CSV) and qualification of laboratory or production equipment / utilities / facilities through the preparation of the necessary documentation.
Participate as SME to the URS preparation in support to the User for all defined steps.
Perform the impact assessments, design, prepare the commissioning and qualification / validation document and qualification/ validation reports.
Collaborate in the upgrading documents and life cycle management of existing production / laboratory equipment, facilities and utilities according to a predefined frequency and in accordance with current SOPs.
Maintain the validation status of existing computerized systems according to a predefined frequency and in accordance with current internal SOPs.
Ensure compliance of the validation standards of the computerized systems through the continuous updating of procedures, according to international GMP standards and internal procedures.
Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning and qualification process are assessed and resolved
If this or other positions in the Life Science industry would be of interest for you, please do not hesitate to get in contact.
The best way is to send me an email with your updated CV to
Best Regards