Global IT Infrastructure Compliance Lead / Pharma life sciences Infrastructure-Latest Vacancy Dec 2014

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Global IT Infrastructure Compliance Lead / Pharma life sciences Infrastructure    

Westlake Village, CA

Posted Date: Nov-26-14


QA / Testing ; x-Other
Work Authorization
   US Citizen
   GC
   TN / EAD(GC,L2)
   H1B
   Others
Pref. Employment
   Corp-Corp
   W2-Permanent
   W2-Contract
   1099-Contract
   Contract to Hire

Job Details
Experience Level :  Senior,Architect
Rate/Salary ($) :  Market
Domain :  Pharmaceuticals
Direct Client Requirement
Mandatory Skills - Pharma, Validation, 21 CFR Part 11, GMP, GAMP

Job Description
Role: Global IT Infrastructure Compliance Lead / Pharma life sciences Infrastructure Tester / Pharma Validation Tester 
Location 1: Vernon Hills, IL 
Location 2: West Lake Village, CA 
Type: Contract 

Detailed JD 
Global IT Infrastructure Compliance / Lead 
An excellent communication skill to effectively interact & communicate with the team, client SME’s / SPOC’s, Quality Managers, Project / Program Governance Board, Regulatory Agencies. 
Relevant experience 8 + Years of relevant experience 

Technical Expertise Competency 
An excellent technical know-how on Global Infrastructure Lifecycle Management - Data Centers, Critical Network Components/ Cloud Computing 
Requirements Analysis and Conceptual design/ Overall Solution Architect 
An excellent technical know-how on various monitoring & control systems - 
o IT Infra. KPI’s Monitoring & Control Systems 
o Incident & Change Management/ Physical & Logical Access Control Systems 
o Enterprise Security Risk Mitigation & Controls viz. Firewalls, IPS, Vulnerability etc. 
o CSV Infrastructure Processes & Pharma Domain Regulatory Compliance Experience - 
Process compliance expertise in view of the following: 
o Overall Solution designing for IT Infra. Project & Service Delivery aligned with the applicable regulatory requirements, ITIL Framework. 
o Good Know-how on the applicable regulatory requirements– ISMS, SOX 
o Providing required process compliance expertise support / lead the team for deployment and maintaining the systems in a compliant manner. 
Pharma Domain & Regulatory Compliance expertise 
Risk Assessment, Governance & Controls 
Data Privacy, Integrity & Security – Adherence Privacy Law, Cyber Law 
Infrastructure Lifecycle Management in a compliant manner - Achieving Qualification/ Maintaining Qualification/ System Retirement 
Expertise in Process Governance and Compliance - Project Deliverables Lifecycle Management/ SOP’s, standards, WI’s Lifecycle Management 
Audits Management - SPOC for interacting and managing the internal and external audits in a compliant manner; SME - Providing key expertise support for regulatory audits. 

5 - 7 years’ experience in Pharma Quality & Compliance. 
Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards. 
Experience in Computer system validation and knowledge of GAMP 5 
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/validation reports. 
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. 
Experience in Software Development Lifecycle (SDLC 
Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. 
Experience in Change Control. 
Experience on various FDA standards (21 CFR Part 11, 210, 211, 820) 
Experience is creation of SOPs. 
Knowledge of FDA guidance’s and industry standards (i.e., GAMP5) 
Hands on experience in HP Quality Center and QTP. 
Strong verbal and written communication skills. 
Able to work as a team player, lead a team or accomplish tasks without supervision. 
Ability to work with remote teams and support several changes/projects simultaneously. 
Flexibility to work with an onshore/offshore model. 
General 
A Bachelors’ degree 
Excellent Communication Skills 
Excellent Stakeholder Management Skills 

Regards, 
Lijo Philip 
Technical Recruiter 
ReqRoute,Inc

Source : science career

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