US: Quality Computer Systems
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please visit http://sqa.fyicenter.com
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
Team SQAFYI - Software QA Resource FYI