* Hi All,
Just wanted to chek if you have any one for the below req . Please shoot the resuem to [EMAIL PROTECTED] with the rate ;contact detials and current location Position: Quality Analyst with Compliance exp* *Location: La Jolla, CA* *Duration: 6+ Months* *Rate: $45-48/Hr Best* ** *Interview process: **Telephonic followed by in-person interview.* ** *Must have COMPLIANCE & VALIDATION exp.*** ** *Description:** * * *Responsibility includes - with supervisions: Provide quality engineering support in the agile development of customized software tools/applications for R&D environment Assist in translating the quality attributes from user requirements to effectively scale software development lifecycle processes to meet business needs Apply quality concept and tool sets, create quality metrics, measures and survey. Contribute to the process implementations planning and post implementation of monitorings and feedback. Using technological tool (e.g. SharePoint), assist in bringing awareness and communications of quality and compliance practice. Assist in conducting internal compliance review in support of departmental needs in compliance of corporate, legal, security and safety requirements Tracking corrective actions and identifying the area of continuous improvement. Provide support for departmental record management in compliance with corporate and divisional policy and requirements. Create, maintain, manage and/or coordinate the storage/archive of the internal records and e-signature processes. *Qualifications:* *Prior working experience in Quality and Compliance organization in Pharmaceutical industry. (THIS IS A MUST)* *Prior working experience in software quality engineering and quality assurance* *(THIS IS A MUST)* Experience in using software development lifecycle and Information Technology processes. Hands-on experience in record management process. Experience as a technical writer is a plus. Highly Proficient in using software tools such as *MS Office, Visio, Documentation management system (Documentum, SharePoint), etc.* *Knowledge in regulations including GXPs and Part 11.* *(THIS IS A MUST)* Effective written communication as well as verbal communications. *Other attributes:* Demonstrate strong ability for self initiation of the task, proactively seek problem solving alternatives. Strong analytical skills and results driven. *Desired:* *Technical Skills & Knowledge: * Software Development Lifecycle Computer System Validation Regulatory environments (e.g. GAMP, IQ/OQ/PQ), Security and 21 CFR Part 11 *Business Skills & Knowledge: * GCP/GLP/GMP Project Management Leadership and influencing skills *CMM * *Industry/Sector Skills & Knowledge: * Pharmaceutical Industry Experience Predicate rules (US & EU primarily) Compliance & Validation** Thanks & Regards, Sophia Jones Direct: 732-734-4505 Main: 1-732-791-2348 xtn: 250 Fax: 732-907-1174/732-960-2339 Email: [EMAIL PROTECTED] Website: www.datagroupinc.net Certified Minority Women Owned Business Enterprise (MWBE) & Small Business Enterprise (SBE) ________________________________________ Note: Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include contact information and a remove link for removal from our mailing list. To be removed from our mailing list reply with "remove" and include your "original email address/addresses" in the subject heading. Include complete address/addresses and/or domain to be removed. We will immediately update accordingly. We apologize for the inconvenience if any caused to you. ________________________________________ --~--~---------~--~----~------------~-------~--~----~ 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 -~----------~----~----~----~------~----~------~--~---
