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Job Search Results: Jobs 1 - 1 of 1  View Titles Only  Page 1 of 1
 
Title   Company Name     Location   Date  
Computerized systems validation engineer 

  Comply    All   1/4/2015 
Category: QA - Quality Control, IT/Hardware/Software  
Education: Bachelors   Position type: Full Time  Experience: No experiece 
Area(s) of expertise desired: Business Analyst, Compliance, GLP, GMP, Information Systems, Medical Device, Other, Professional Services, Validation  
Description:
•Write Computerized systems validation documents and test protocols: STP,STD,IQ,OQ,PQ
•Write Computerized systems design and summary documents: URS,FRS,VP,STR,VSR
•Write SOPs ( Standard Operating Procedures) , Work instructions
•Write software applications reject lists, bug identification, report and monitoring.
•Functional testing of life-science computerized systems.
 
Requirements:
Minimum Qualifications

•Education: BA/BSC in Biotechnology, Chemical Engineering, Biomedical engineering, Chemistry, Biology, Computer Science
•Communication: Excellent oral and exceptional technical writing skills with the ability to interface effectively and professionally at all levels.
•Organized person with high ability to work with fine details.
•Excellent English( Equal to mother tongue).
•QA oriented : Experience with QA in the life-science industry( Pharma ,Biotech and Medical devices). Optional- Experience with QC in the life science industry.
•Service oriented.

Preferred Qualifications

•Experience with use of life science computerized system ( e.g. LIMS, ERP systems, computerized Lab systems ( Empower, FTIR etc..), production systems etc.)
•Experience with IT subjects (i.e. Server- Client topology, Data backups, Help Desk etc.)
•Experience in software testing\ computerized system validation in the life science industry
•Knowledge in roles and guidelines: 21CFRPart11, GAMP5 ISO 14971:2007,IEC 62304
 
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