Hello Hope you are having a wonderful day.
My name is *Varun Kakkar* and I am a part of recruitment team at *United Software Group (USG).* I came across your profile and wanted to see if you would be interested in Position as * Validation Lead with *one of our customer located *in Chicago, IL.* Please let me know your thoughts on this exciting opportunity with us. *Feel free to reach me out at [email protected] <[email protected]> or call me at 614-401-5197 Ext- 672* * Job Title : Validation Lead* *Location : Chicago, IL* *Technical/Functional Skills * - Excellent understanding of Quality & Compliance in an IT environment - Experience in Information Technology, performing computer system validation activities, including authoring/review/approval of computer system validation deliverables, including requirements gathering, test plans, test scripts/cases, traceability, and summaries. - Experience in Inspection Readiness and Periodic Review activities - Working experience of GxP regulations, 21 CFR part 11 compliance processes. - Exposure to Regulatory inspections including interactions with auditors and inspectors - Training and experience in the use of HP Quality Center and similar tools to manage software testing and requirements. - Training and experience in the use of document management systems in a regulated environment. - Experience with risk based approaches to validation in regulated environments. - Experience coaching and guiding teams to produce software development lifecycle deliverables. - Demonstrated skills for independently guiding quality and compliance activities during system development and implementation. *Roles & Responsibilities * - This individual is responsible for the following functions: - Interact with Project team and Business Representatives to understand the scope and purpose of the business process work stream. - Provide consultancy to IT teams related to quality and compliance of IT managed projects. This includes providing guidance (answering questions, addressing compliance issues) on the governing solution delivery life cycle to the project teams as appropriate. - Review / approve IT solution life cycle records requiring QA approval for projects, such as plans, requirements, testing documents, deviations, and summaries. - Author documentation as required. - Initiate or review and approve Compliance Risk Profiles of High or Medium compliance risk category. - Collaborate with Business Unit Quality Assurance and corporate teams’ representatives for impact to projects when medium or high risk data (GxP, SOX, Data Privacy, etc) has been identified. - Provide oversight to ensure compliance requirements are analyzed and met or deviations raised. - Work closely with Document Coordinators in ensuring the documents get approved and uploaded to the correct records repository - Work closely with the Project Manager and Technical Writer to complete the project tailoring and scale deliverables (as needed) - Review Test cases and Traceability Matrix very closely ensuring compliance requirements are tested ( if in scope) - Ensure that all Regulated Systems are Audit/Inspection ready *Kindly Reply me back with all these details and your updated resume, if you are comfortable with this requirement*. Title (Mr./Mrs./Miss): Legal Name First Name: Middle Name (if applicable): Last Name: Date of Birth: Gender: Nationality: Available from: SSN(Last 4 digit) Contact Number: Email ID: Total IT Experience (Years): Experience in Required Skills (Years): Key skills Location Grade / Years of Experience: visa status: Educational details: Name of Degree: Specialization: Duration Start Date (mm/dd /yyyy): Duration End Date (mm/dd/yyyy): University: Type (Full time / Part time): Best Time for interview:- Hourly Rate: Skype ID Thanks And Regards Varun Kakkar United Software Group Inc.. 565 Metro Place South. Suite # 110 Dublin, OH 43017 Phone: 614-401-5197 Ext- 672 Fax: 1-866-764-1148 *[email protected]* <[email protected]> *www.usgrpinc.com* <http://www.usgrpinc.com/> -- You received this message because you are subscribed to the Google Groups "Oracle Users" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/oracle-users. For more options, visit https://groups.google.com/d/optout.
