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Posted: Tuesday, March 7, 2017 10:48 AM

Job Description:/h3:
We are seeking a Quality Assurance (QA) Consultant : Specializing In CSV to become an integral part of our team
** Chemical, Mechanical, Electrical engineering required (Bachelors of Science Degree)
** 5 + years Computer Systems Validation required (minimum)
** additional 5+ years working as QA consultant for Pharmaceutical, Biotechnology, Device Manufacturing Company (west coast preferred).
** direct experience with CSV review/approval, SAP, Doc Control Systems, QC Systems, LIMS, DCS, MES, BMS systems
Responsibilities:
:Provide QA guidance for Part 11, CFR Part 210, 211, 820 and related regulations to project teams
:Assist in Validation planning, risk assessment, requirements
development/approval
:Assist in managing and reviewing validation deliverables.
:Assist in developing and reviewing SOPs, manufacturing work instructions.
:Familiar with all business processes within pharmaceutical, biotechnology, device manufacturing processes
Qualifications:
:Engineering degree with 10+ years validation AND QA consulting experience, with solid references
:Previous experience in software development, quality assurance, or other related fields
:Familiarity with relational databases such as MySQL, Oracle, and SQL Server
:Experience with all business, QC, QA, manufacturing, and facilities systems supporting Pharmaceutical, Biotechnology, and Device manufacturing
:Strong root:cause analysis skills
:Deadline and detail:oriented

Source: https://www.tiptopjob.com/jobs/63960894_job.asp?source=backpage


• Location: San Francisco

• Post ID: 56695688 sf
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