Validation Lead-Chicago,IL Job Chicago area,Illinois USA,Engineering

Validation Lead

Location:

Chicago, IL Rate: DOE $/Yr. Position Type:
Full Time Interview Process:
Phone Followed by F2F US Citizen, Green Card and GC EAD

Technical/Functional Skills

1. Expert knowledge of and experience with regulatory agency regulations such as FDA GLPs, predicate rules, and 21 CFR Part 11 2. Experience in assessing the validation strategy of IT and infrastructures based on the defined SOP's 3. Proven track record of leading the timely completion of computer system validations.
4. Extensive experience authoring computer system compliance risk validation materials in accordance with FDA GxP regulations, and 21 CFR Part 11 guidelines
5. Hands on experience in using Test management tools like Client ALM/QC 6. Experience in working in Global Delivery model
7. Good co-ordination skills
8. Excellent communication

Roles & Responsibilities

Accountable/Responsible for leading the regulatory compliance team from onsite. These responsibilities will span

Author, review and manage validation team and validation deliverables:

Project Plan
Contribution to Data Privacy Plan
Contribution to FRS, Requirement Analysis
Contribution to Integrated Risk Assessment
Identification Of Supporting System Documentation (ISSD)
Validation Plan
Test Plan

Designing and reviewing SOPs/Work instructions

Review and approve all documentation and deliverables

Perform Compliance Risk Profiling

Monitor all audit activities, Conduct Internal Compliance checkups/periodic reviews on Regulatory tools (knowledge management)

Groom the offshore resources in the regulatory compliance area

Design audit/assessment programs

Review the design of key compliance controls from infrastructure perspective

Test the design of controls and operating effectiveness of these controls

Provide a formal report on the compliance status of various processes such as

Access to Systems and Data

Validation Lead-Chicago, IL