Perform periodic and change control related re-qualification activities;
Prepare, execute, review and approve internal qualification protocols for facility infrastructure systems and equipment;
Coordinate, assist and document outsourced qualification activities;
Prepare and update qualification and validation SOPs;
Participate in process, cleaning and/or analytical method validation activities;
Draft, review and approve other qualification, validation and GxP compliance related documents;
Provide training to colleagues and contractors on our approach to systems implementation and validation SOP's;
Coordinate meetings, document issues, action items, meeting notes, and perform appropriate follow up related to qualification and validation activities.
Requirements
Minimum of a Bachelor's degree in the field of mechanical/ automation/ electronics/computer or other technical engineering;
Experience in preparation and ability to read and interpret technical functional specifications, technical drawings, electrical schemes, technical manuals and similar documents;
Experience in validation, maintenance or quality assurance preferred;
Attention to details, ability to identify deviation root cause effectively, efficient problem solving skills;
Ability to function independently or in a cross-functional team
Experience in GxP preferred;
Fluent English language skills (verbal and written).
Klausimai ir atsakymai
Užduokite klausimą:
Jūs galite pateikti klausimą darbdaviui. Klausimas atsiras skelbime iškart, kai tik darbdavys atsakys į jį. Lanktytojai negalės matyti jūsų el. pašto adreso.
Persiųsti
Nuoroda į skelbimą bus pridėta automatiškai žinutės pabaigoje.