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.

To apply for this position, please visit this Website.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com