SQAFYI - Software QA Resource - FYI

US: Quality Computer Systems

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 26-Sep-2013

Quality Computer Systems

In conjunction with site Quality Assurance, assures business requirements and specifications for new computer systems meet regulatory requirements. Assures system compliance with federal regulations and Company policies, procedures and standards. Provides QA review and approval of protocols and reports for validation of corporate computer systems. Provides QA review and approval of change control requests for corporate computer systems. Provides QA review and approval of corporate Standard Operating Procedures (SOP's) related to computer systems. Supervise subordinate personnel. This position requires up to 20% global travel. Qualified candidates will have the knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), 21 CFR Part 11, Annex 11 and other regulatory requirements. Principles and practices of computer validation and qualification. Experience with Quality related Computer systems and software applications used in the Pharmaceutical Industry - such as SAP, JDE, Argus, EDMS, LIMS, Trackwise, LMS, etc.. Project management practices and techniques. Principles of mathematical and statistical computations. Skill in implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources. Candidates will have a Bachelor's Degree in Biology, Chemistry, Pharmacy, Engineering or similar related field from an accredited college or university. Five to seven (5-7) years of Validation or Quality experience in the pharmaceutical industry. Three (3) of which must be in a supervisory capacity or an equivalent combination of education and experience.

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Thank you,
Team SQAFYI - Software QA Resource FYI

US: Quality Computer Systems