CSV Consultant
K-Tek Resourcing LLC
Dice Job Match Score™
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Job Details
Skills
- GxP
- Computerized System Validation
- GAMP
Summary
Role: CSV Consultant Location: Raritan, NJ (Hybrid) Duration: Long Term
Job Details:
- Experience in the Pharmaceutical, biotechnology, or medical device industry
- 2+ years’ experience with System Development Lifecyle
- 3+ years’ experience in Computer System Validation (Based on the role selected)
- Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
- Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
- 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 QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Strong verbal and written communication skills.
- Ability 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
Thanks & Regards
Darshan Neema
Client Account Manager, KTEK Resourcing
O E
W
A 2277 Plaza Dr. Suite 240, Sugar Land, TX 77479
- Dice Id: 10411276
- Position Id: 8827940
- Posted 30+ days ago
Company Info
Vision
To be a trusted partner and advisor to our customers
Mission
At K-Tek we believe in understanding the specific needs of the customer and tailor-creating innovative solutions to meet these needs. We invest in our employees and customers. We build a relation of trust with our customers through empathy, solutions and being the first time right.
Who We Are & What We Do
K-Tek Resourcing is a consulting organization with offices in Houston TX and St. Paul, MN. It is supported by 2 global delivery centers, located in India. With its global employee strength of over 250, K-Tek has been supporting its clients for over 9 years. We have been consistently achieving a growth of 30% Year on Year. We have an extensive experience of working in domains including BFSI, Retail, Healthcare and Pharma, Oil & Gas, Travel & Hospitality and Insurance. The technologies we service are IT Infrastructure, Mobile Technologies, Cloud & Big Data Solutions. We understand the needs of our customers and provide them with customized solutions and resources with the tenet of being the "First Time Right".
Values
-Commitment to our customers success through Integrity
-Excellence through Quality
-Growth through customer value creation
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