Hi, Hope you are doing great! Please find the requirement below , If you find yourself comfortable with the requirement please reply back with your updated resume and I will get back to you or I would really appreciate if you can give me a call back at my contact number
*614-495-9222 * 484 Position: Lead Validation Consultant* *Location: Chicago, IL Duration: 6+ months* *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 *Please Send me your resume and fill your details in below mentioned table.* Title (Mr./Mrs./Miss): Legal Name First Name: Middle Name (if applicable): Last Name: DOB 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): Skype ID Best Time for interview:- Hourly Rate: Thanks & Regards Prateek Bhardwaj United Software Group Inc.. 565 Metro Place South. Suite # 110 Dublin, OH 43017 *Phone: 614-495-9222 * 484 Fax: 1-866-764-1148 **pratee...@usgrpinc.com* <pratee...@usgrpinc.com> *www.usgrpinc.com* <http://www.usgrpinc.com/> To unsubscribe from this mailing, please reply to this email with the word UNSUBSCRIBE <techsupp...@usgrpinc.com,pan...@usgrpinc.com?subject=UNSUBSCRIBE%E2%80%9D.>in the subject line, or click here. -- You received this message because you are subscribed to the Google Groups "Oracle Developers" group. To unsubscribe from this group and stop receiving emails from it, send an email to oradev+unsubscr...@googlegroups.com. To post to this group, send email to oradev@googlegroups.com. Visit this group at http://groups.google.com/group/oradev. For more options, visit https://groups.google.com/d/optout.
