Hi, We are looking for consultants for the below mentioned requirement. If you find yourself suitable for the position, please send your updated resume along with your employer details if any and bill rate per hour ASAP. QA Validation Lead - FDA Validation/Qualification Start Date: 1/4/2010 Duration: 12months Location: Dublin, OH Rate: $60/hr Max (Locals preferred)
Job Description: · Oversee computer system validation activities on multiple projects to ensure efficient and cost-effective compliance with FDA requirements and Quality System. · Support the design, development, installation and qualification of new and modified computer system hardware and software by creating, reviewing and approving computer systems validation documentation including validation plans, test plans, test scripts, traceability matrices, training and summary documentation. · Ensure appropriate archiving of validation documentation consistent with CAH procedures and FDA regulations. · Employ a risk-based approach to recommendations on required validation activities. · Coordinate validation activities for all project team members. · Anticipate potential compliance issues in project activities. Work to avoid/remediate compliance issues as necessary. · Assist in review of business requirements to determine need for validation activities. · Represent Quality & Security Assurance team on validation issues with Health management, project teams, and internal/external inspectors or auditors. · Develop SOPs as required pertaining to validation processes. · Suggest improvements to current validation processes, templates and documentation to align Health validation activities with GxP regulations and industry best practices. · Work closely with management at all levels to identify and proactively recommend corrective or preventive actions in order to maintain/improve compliance with regulations. Requirements: · Minimum of a bachelor's degree in an IT discipline, business, quality management or related fields. · Minimum of 6 years validation experience with a CSV or QA organization involved in regulatory activities · Comprehensive knowledge of FDA requirements, including 21 CFR Part 11, 211, and 820 as they pertain to computerized systems. · Ability to work with minimum supervision · Ability to pay close attention to detail while maintaining the perspective of the "big picture". · Ability to handle multiple, concurrent projects. · Excellent organizational, analytical, and problem-solving skills. · Ability to shift priorities to meet a constantly changing environment · Ability to build consensus and affect change across departmental boundaries. · Strong interpersonal and communication skills. · Ability to explain and defend position on validation issues. Must be willing to raise objections as needed to ensure compliance with regulatory issues. · Strong computer skills including QA applications, word processing, spreadsheets, and databases. · Ability to work with diverse functional groups. · Pharmaceutical or medical device industry knowledge is a plus. • Occasional domestic travel may be required. Thanks & Regards, Riaz Deen| IT Recruiter | AIT Resource Group Inc. 2500, West Higgins Road, Suite 1273 | Hoffman Estates, Illinois - 60169 Phone: 847-598-4444 Extn 8805 | Fax: 847-594-6069 mailto:[email protected] | http://www.aitresourcegroup.com Yahoo IM: r_i_111 | Important: This electronic mail message and any attached files contain information intended for the exclusive use of the individual or entity to whom it is addressed and may contain information that is proprietary, privileged, confidential and/or exempt from disclosure under applicable law. If you are not the intended recipient, you are hereby notified that any viewing, copying, disclosure or distribution of this information may be subject to legal restriction or sanction. Please notify the sender, by electronic mail or telephone, of any unintended recipients and delete the original message without making any copies
