| Senior Systems Analyst, Validation and Testing |
Job Id: W280612 |
Posted On: 1/4/2010 |
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Location: Philadelphia, PA;
Job Type: Full Time
Salary: $86000.00 to $96000.00/year
Degree: Bachelor
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Description
Job Responsibilities
Provides direction in the areas of test strategy and management to project teams
Determines risk management and mitigation plans
Review of test strategy/approach/ plan for different test engagements (scalability, performance and robustness)
Implements Validation and test strategies for both local and global projects
Manages the validation aspect of assigned IT projects
Ensures that global IT procedures and policies are followed consistently as defined by QMS. Follows the appropriate global regulatory guidelines such as 21CFR part 11, 210, 211 and current Goods Manufacturing Practice (cGMP).
Collaboratively works with other IT members, business representatives, vendors, and consultants to effectively implement solutions.
Develops mutually productive relationships in the workplace and contributes to the team.
Develops Validation Test Protocols and executes independent testing for local and global applications adhering to applicable regulatory guidelines.
Performs validation pre and post execution review of test protocols and output.
Assists individuals in developing and executing good test scripts. Provides guidance and internal training on testing techniques and sufficiency of testing.
Leads an effective and efficient requirements gathering effort (user, business process, performance requirements, etc.) from business users using appropriate mechanisms and following company standards.
May perform matrix management and project roles for local/global projects.
Identifies and implements means to improve the qualities and efficiencies of IT processes, systems and results.
Escalates issues when needed to appropriate levels of IT/Business and present proposals for resolution to Management.
Training and Experience:
BS degree in a computer-based discipline (e.g. Computer Science, Information Systems) or a technical discipline (e.g. Engineering, Mathematics) or equivalent combination.
Computer Validation or Quality experience in a cGxP environment required.
Knowledge of Computer Validation principles and Quality System management required.
Minimum 2 years working experience with integrated enterprise systems with demonstrated advanced knowledge in the role of Systems/ Business/ Validation analyst
Must be knowledgeable with all aspects of SDLC (Systems Development Life Cycle).
Experience with Quality Center, QTP and LoadRunner highly desirable
Thorough knowledge of the Code of Federal Regulations, GxPs, FDA & EMEA regulations governing validated applications including 21CFR Part 11 a must.
Knowledgeable about all aspects of validation documentation including Validation plan, Risk Assessment, IQ, OQ, PQ, data migration protocols, Test Plan, Test Report and Validation report
Experience in testing including thorough knowledge of strategy planning, reporting and metrics analysis
Wide knowledge of industry and challenges specific to testing
Should have exposure to global delivery model and offshore resourcing
Knowledge of configuration management and defect management tools
Strong skills needed in the areas of problem analysis, decision making, delivery of results, adaptability, flexibility, global perspective and strong time management and organizational skills.
High level of computer literacy with Microsoft Office products (i.e. Project, PowerPoint and Visio)
Excellent Detail Orientation and written/verbal communication skills required
Self starter with strong process improvement and quality skills and the ability to manage multiple tasks and projects simultaneously required
Knowledge of automated testing tools, document management and change control systems a plus.
Experience working in global teams a plus
Experience working in SAP Validation preferred
HIPAA, CLERP 9 and Sarbanes Oxley knowledge a plus.
Auditing Experience preferred
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