Hi,
Kindly check if you can submit some good match on this urgent requirement. *Profile: Quality Manager* *Location: Portland, OR* *Duration: 6+ Months * POSITION SUMMARY: This is a temporary position under the direction of the Information Systems (IS) and Compliance groups. The main objectives are to drive implementation of standardized corporate policies for software system development life cycle (SDLC) and lead the remediation process for gaps previously identified in existing systems. The initial contract length is 6 months. RESPONSIBILITIES: • *Ensure software systems meet FDA requirements, including compliance with 21 CFR Part 11*. • Implement policies covering corporate software development life cycle (SDLC), including phases for requirements, design, development, system validation, change control, security, and archival. • Manage development and implementation of SDLC procedures for corporate computer systems and provide associated employee training. • Develop a plan to resolve known deficiencies for compliance of existing software. • Assign priorities to address software compliance deficiencies and collaborate with relevant staff for remediation. • Perform audits of regulated systems and related data as needed to assess FDA compliance. • Inform Management team of any new risks, findings or remediation outcomes likely to have an impact on FDA requirements. • Ensure documented SDLC procedures comply with FDA regulations. REQUIREMENTS: • BS in information systems, software engineering, or related field. •* 5 years experience with software quality assurance.* •* 3 years software experience in a FDA regulated environment (pharmaceutical or medical device industry experience – plus). * • Experience in managing multiple projects and creating alignment with different groups. • Experience with SDLC process for enterprise applications. • Strong knowledge of computer systems, LAN, technical support, systems analysis, application programming, and ancillary services. • Excellent written and verbal communication skills. • Entrepreneurial leadership drive and prior experience in creating and developing policies/procedures. -- Unfeigned Regards | Sam | Technical Resource Specialist |Techclique|| www.Techclique.com| Phone: 1-732-357-3828| Fax: 1-732-357-3846| Msn Id:[email protected]<id%[email protected]>or [email protected] Email: [email protected] or [email protected] "A player that makes a team great is more valuable than a great player." --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Oracle-Distribution" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/Oracle-Distribution -~----------~----~----~----~------~----~------~--~---
