Kforce is seeking a Consultant with a dual reporting relationship into IT and Quality Management for a Franklin Lakes, New Jersey client. The incumbent will be required to work collaboratively with Quality, IT, Business Partners, and Software Vendors to execute data migration from Legacy software to a new system.
Primary Responsibilities (specific responsibilities will include):
- Coordinate and execute the data migration activities for 50+ locations to work with the migration of master equipment data from Legacy systems to a new Enterprise Calibration Management System
- Develop and execute a plan to extract, cleanse, and map Legacy data into the new format to be loaded to the new system
- Write Back End SQL and Oracle queries to extract data from Legacy systems
- Perform data migration validation to verify that data are migrated correctly from Legacy system to new system
- Be responsible for the preparation, approval, and/or execution of certain validation deliverables (Test Protocol/Cases and Validation Summary Report) to make sure they comply with BD IT Computer System Validation Procedures and applicable FDA/ISO regulatory requirements
- A Degree in Computer Science or Engineering
- Practical knowledge in data migration including data extraction, cleansing, mapping, loading, and data verification
- 2-5 years of work experience with SQL and the Oracle Database to include writing/designing queries, functions, and procedures
- Practical experience in Microsoft SQL Server querying and schema development
- Practical knowledge in relational database structure, design, and queries
- 5 years of experience in writing Crystal Report are a plus
- Advanced user of Microsoft Excel
- Demonstr ated ability to work effectively within a Systems Development Lifecycle Methodology
- Working knowledge of testing concepts, verification, and validation techniques, and risk management
- The preferred candidate will have prior experience performing system's validation in regulated industries (pharmaceutical/medical device manufacturers)
- Writing, reviewing, and/or approving SDLC validation deliverables throughout all phases of a system implementation
- Practical working knowledge of cGMP, FDA QSRs, ISO 13485, FDA/ISO regulations relevant to Computer and Software Systems Validation
- Candidate must strive to interject quality into all tasks and deliverables assigned without sacrificing timelines and customer good will
- Must have ability to develop creative solutions that maintain compliance to policies and procedures and still meet project/user goals
- Excellent communications skills; written and verbal
- Excellent fo llow-up and documentation skills
- Practical experience working with or within an Information Technology Organization
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