*Position: Validation QA EngineerLocation: Lake Forest, IL.Duration: 12+ Months On-Site contract plus extension*
*Interview mode: Phone than SkypeJob Description:* *Job Title* Validation QA Engineer *Relevant Experience (Yrs) * 5 years plus . *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. *Total Experience Required* 5-8 years *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 BT teams related to quality and compliance of BT 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 BT solution life cycle records requiring BTQA 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 *Generic Managerial Skills* · Experience in the pharmaceutical or biotech industries supporting IT initiatives · Minimum of a Bachelors degree, preferably in sciences · Experience managing activities within medium to large scale IT projects · Demonstrated ability to communicate and negotiate with individuals and groups at multiple levels across the organization · Ability to work independently, manage multiple priorities, and work in an unstructured environment · Must have excellent interpersonal skills and have the ability to guide colleagues though the software development lifecycle. · Must have a high degree of attention to detail to ensure high quality deliverables and reviews / approvals. · Must be self motivated and have the ability to take initiative and work independently with minimum direction and to take responsibility for ensuring deliverables are produced to the required quality within timelines. · Excellent written and verbal communication skills required and must have ability to openly communicate with stakeholders at all levels of the organization. · Must have excellent project management skills and ability to manage multiple projects simultaneously. · Must have a high level of integrity. · Ability to prioritize under pressure and have a sense of urgency. · Committed to customer services and be able to go the extra yard to ensure customer requirements and timelines are met. *Education * A minimum of bachelors degree in life science or computer science with 5-8 years of relevant experience in pharmaceutical industry *Work Location* Lake Forest (Chicago) IL *.* If interested than please fill this form and kindly send back to me ASAP. *BASIC Details* Requirement ID -------------- Title (Mr. / Ms.) First Name Middle Name Last Name SSN No(Last Four Digits) Date of Birth Gender Nationality/VISA Status/Current validity Available From Current Location Relocation Contact Number Email ID Skype ID Interview Availability (Any 3 Time Slots) Total IT Experience Experience in required skills Grade/Years of Experience Skills (Please Mention if any Certifications) *Educational Details* Name of Degree (Bachelors/Engineering) Specialization Duration Start Date(Month & Year) Duration End Date(Month & Year) % Marks/Grade University Education (Regular /Distance) *Employer Details* Company Name Contact Name Contact No Email ID Thanks Tushant Jain United Software Group Inc.. 565 Metro Place S. 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