V-Soft Consulting is currently seeking a?Sr IT Test Analyst (Pharmaceutical/ Medical)?for our premier client in?Elkton, Maryland.?This is a?contract?position in the?manufacturing industry.
Education and Experience ?
- Bachelor’s degree in an applicable science
- At least 3 years of progressively responsible IT and/or QA experience.
Experience with the following software systems/applications:
- ERP
- Change management
- Configuration management
- Product lifecycle management
- Laboratory information management
- Mobile
- Middleware
- Business intelligence
- Master data management
- Manufacturing execution systems.
Knowledge, Skills and Abilities ?
- Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, ISO13485:2003, EU GMP
- Annex 11 and the European and Canadian Medical Device Directives
- Demonstrated experience in product risk management (ISO 14971)
- Understanding of current software quality techniques and industry standards such as ISO, IEEE, AAMI, and GAMP
- At least 3 years of experience in a quality assurance, information technology, or automation and computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry
- Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques
- Understanding of current software quality-assurance techniques and software industry standards and their impact on internal procedures, and software quality
- Demonstrated project management and leadership skills
- Excellent written and oral communication skills
- Proficiency in interacting with contacts, including project teams and vendors
- Highly motivated and assertive
- Demonstrated ability to work in a dynamic team environment.
- Ability to: Handle multiple projects and priorities with competing resources
- Communicate clear direction, commitments, and alignment
- Partner broadly, Be both flexible and determined, Train others
- Participating with stakeholders in the preparation of software and hardware specification documents and test plans
- Participating in developing software quality assurance processes and implementing standard operating procedures. Developing and delivering training programs in support of software testing concepts, practices, and requirements
- Developing and implementing effective corrective and preventive actions
- Authoring, reviewing, and/or approving system change, configuration management, and supporting documentation activities
- Preparing for and participating in external/internal computer system/software audits
- Contributing to process improvements by developing and updating written procedures related to computer systems testing
- Supporting and monitoring defect resolution
- Supporting and monitoring the qualification of Information Technology Infrastructure Platforms
- ?Ensuring that test cases are documented and executed following the requirements set forth by procedures and external requirements
- Providing leadership, oversight, and training related to test case development to multi-functional teams
- Providing oversight for test cases used in the validation of software, hardware, and networks, including risk-based approaches
- Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements Working with appropriate teams to establish quality expectations related to test planning and execution
- Develops, implements and maintains policies, procedures, programs and the overall plan for ensuring the security and integrity of company data, databases, information systems, and technology.
- Conducts risk management analysis and creates disaster recovery plans.
Qualified candidates should apply or send their resume to [email protected]
