CSV Specialist
Publication date:
15 September 2024Workload:
100%Contract type:
Permanent position- Place of work:Chur
Land USA
Stadt Grafton, Wisconsin
Funktionsbereich Operations
Jobgruppe Compliance
Beschäftigungsart Unbefristeter Vertrag
Arbeitszeit Vollzeit
Land USA
Stadt Grafton, Wisconsin
Funktionsbereich Operations
Jobgruppe Compliance
Beschäftigungsart Unbefristeter Vertrag
Arbeitszeit Vollzeit
Ihre Rolle
SUMMARY:
The Computerized Systems Validation Expert will lead and provide overall CSV activities of the GMP Computerized System used on Grafton Site.
The position will support also in the creation/maintenance of necessary procedures, and assist in the configuration/customization of the Laboratory System.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
Ihr Profil
EDUCATION AND EXPERIENCE:
OTHER REQUIREMENTS:
· ISPE GAMP , ideally Good practice guide Laboratory / manufacturing systems
· Two years+ experience supporting laboratory systems in a R&D or QC laboratory in a cGMP regulated industry.
· Excellent verbal and written communication skills.
· Demonstrated working understanding of laboratory operations and practices strong organizational and/or project management skills.
· Strong analytical and problem solving skills.
While performing the duties of this job, the employee is regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
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Wer wir sind
· Early-phase development and manufacturing