HOT REQ - Validation/Quality Management Engineer - Job id - PZ28357ValidationMI -

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Sincerely,
Dave Karlekar
Sunrise Systems
sunrisesys.com">davesunrisesys.com
www.sunrisesys.com
732-603-2200 X-216
732-603-2208 (Fax)
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Job id - PZ28357ValidationMI
Client - Pharma Company
Title - Validation/Quality Management Engineer
Location - Kalamazoo, MI
Duration - 6 Months
Rate - Open

Manager will hire off the phone interview.

Description:
Required Travel: Local Travel Required (150 Mile Radius)   
Requirement Notes: The person will based out of Kalamazoo but will work 20% out of Ann Arbor  

Job Description 
Validation/Quality Management experience within regulatory environment Regulatory environments 
(e.g. GAMP, IQ/OQ/PQ), Security and 21 CFR Part 11
General Function:  Serves the QM organization as a primary point of contact for quality support requests from the Business & Informatics to ensure that computerized systems are developed & managed in accordance with corporate, regulatory & Informatics standards. 
Work closely with Informatics project managers, teams and associated Business QA groups to ensure SLC deliverables are consistent & satisfy the above requirements and meet business needs. 
Tasks include writing, revising, and verifying QM deliverables (Quality Planning & Compliance Reporting), reviewing and approval of SLC deliverables (Project planning, requirements and verification). 
Tasks also include contributing to implementation and post implementation planning and monitoring to support effective 
performance and change management practices. 
Excellent communication skills are required, capable of performing effectively within a project team, or with minimal 
supervision. 
  
Technical Skills & Knowledge:
Software Development Lifecycle

Computer System Validation
Regulatory environments(e.g. GAMP, IQ/OQ/PQ), Security and 21 CFR Part11
Business Skills & Knowledge:
GCP/GLP/GMP
Project Management 
Leadership and influencing skills
CMM
Industry/Sector Skills & Knowledge:
Pharmaceutical Industry Experience
Predicate rules (US & EU primarily)
Compliance & Validation
 

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