Global IT Infrastructure Compliance Lead / Pharma life sciences Infrastructure-Latest Vacancy Dec 2014 - Greetings spirit, friend. Many companies provide jobs, but sometimes the information is only limited to certain circles. Therefore the blog admin of this blog feel called to assist in spreading the job information to all people in need. Who knows, maybe one of them is qualified and desired by companies. Therefore, you must read this following job information, because this information may be the point of your success in reaching your career and future. Please be studied carefully.
Global IT Infrastructure Compliance Lead / Pharma life sciences Infrastructure
Westlake Village, CA
Posted Date: Nov-26-14
QA / Testing ; x-Other
TN / EAD(GC,L2)
Contract to Hire
Experience Level : Senior,Architect
Rate/Salary ($) : Market
Domain : Pharmaceuticals
Direct Client Requirement
Mandatory Skills - Pharma, Validation, 21 CFR Part 11, GMP, GAMP
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
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.
A Bachelors’ degree
Excellent Communication Skills
Excellent Stakeholder Management Skills
Source : science career
Steps for looking for jobs could be difficult because of the high level of competition in search of jobs. This is because the number of vacancies is not proportional to the number of job seekers. To overcome this problem, you must continue to improve the skills and expertise in order to support competition for jobs search. If you feel already meet the above requirements, immediately to send a CV and job application so you immediately got a call from the company above. If the above information does not match your criteria, you would probably willing to share this information to your families, relatives or your friends, maybe they need it. You can also join the our jobs seeker community that we manage on facebook, twitter or google plus. Okay, maybe next job information is more suitable for you : Family Practice Physician (Outpatient / BC) - Miami, FL-Latest Vacancy Dec 2014