תיאור תפקיד:
The QA IT associate will be responsible for conducting QA IT aspects at the company, according to the required CGMP regulations.
Responsibilities:
Responsible for the computerized systems validation including the equipment at the medical device and pharmaceutical labs.
Familiarity with the regulation guidelines (CFRpart11, Annex11, ISO13485, etc.) and managing their implementation
Preparation for regulatory audits
Implement QA-IT SOPs
Vendor controlling and evaluation from QA IT perspective.
Support and conduct External and Internal audits
Support the information systems quality assurance activities
דרישות:
Qualifications:
At least 3 years experience in information systems & regulation in a pharmaceutical or/and a medical device company
Familiar with software regulation requirements such as: CFR 21 part11, Annex11, GAMP5, ISO13485
Experience in software vendor selection process
Demonstration organizational skills and ability and independency.
English language fluency in speaking and writing
Education:
Academic degree in industrial engineering/science an advantage
Advantages:
Experience in global technological projects within the pharma biotech industry
היקף משרה:
משרה מלאה
קוד משרה:
JB-00008
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