Sr. Quality Assurance Analyst, Validation Systems - (US-PA-Wayne - 19089)

Minimum Education: None
Jobcode: 61686560
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Provides "QA" review of all documents in the IT Change Control process. Ensures the adherence to all guidelines.
Performs validation pre and post execution review of test protocols and output. Provides/gains expertise on testing methodologies as well as the use of automated testing tools (load testing, stress testing).
Manages and maintains Quality Management System (QMS). Creates QMS SOPs, Policies and Procedures. Review QMS against regulatory requirements to ensure existing gaps are remediated and new regulations are reflected in the QMS. Assists IS with creation of gap and remediation plans and tracks them till execution. Approves/distributes QMS documents and reviews/controls paper copies of QMS. Manages electronic versions of documents and templates such as test protocols and other change control templates. Coordinates administrative staff in managing paper versions of documentation in Document Control Room, and electronic documentation in documentation system.
Maintains training logs for all required training. Conducts internal training on QMS, Validation, User Acceptance Testing & Change Control Process.
Responsible for maintaining audit calendar and global database accessibility of audit results. Tracks the completion of audit remediation. Conducts internal and external supplier audits.
General Accountabilities:

Responsible for operational execution / maintenance of applications within relevant IT functional areas. Ensure effective problem analysis and resolution in a timely fashion Escalate issues when needed to appropriate levels of IT / Business and present proposals for resolution to management.
Lead an effective and efficient requirements gathering effort (user, business process and performance requirements) from business users using appropriate mechanisms and following company standards.
Translate complex business requirements and design effective solutions. Develop (configure and program) and unit test solutions based on company standards and SOPs.
Participate as necessary in the validation matrix role to independently test and validate solutions to ensure fulfillment of all business requirements, compliance of regulation and quality of solutions.
Ensure global IT procedures and policies are followed consistently as defined by QMS. Follow the appropriate global regulatory guidelines such as 21CFR part 11, 210, 211 and current Good Manufacturing Practice (cGMP).
Identifies and implements means to improve the qualities and efficiencies of IT processes, systems and results.
Conducts research and analysis on new and innovative solutions, releases, enhancements and consider their applicability. Presents results / recommendations to IT / Business management.
Collaboratively works with internal employees, vendors and consultants to effectively implement solutions.
May perform matrix management and project roles for local / global projects.

Training and Experience:

Bachelor of Science in a computer based discipline (e.g. Computer Science, Information Science) or a technical discipline (e.g. Engineering, Mathematics) required.
Minimum 2 years related experience working with integrated enterprise systems with demonstrated advanced knowledge in the role of Systems Analyst.
Computer Validation or Quality experience in a cGxP environment required.
Knowledge of Computer Validation principles and Quality System management required.
Thorough knowledg4e of the Code of Federal Regulation, GxPs, FDA & EMEA regulations governing validated applications including 21CRD Part 11 a must. HIPPA, CLERP 9 and Sarbanes Oxley a plus.
Knowledge of automated testing tools and change controls systems a plus.
Technical expertise (through programming / business analysis) in one of the following software applications a must: SAP, Clintrace, Documentum, Siebel, US Commercial applications, Web applications or custom developed software.
Strong understanding of the Systems Development Life Cycle (SDLC) methodology.
High level of computer literacy with Microsoft Office products
Strong skills in the areas of Project Management, Requirements gathering and Test & Validation required.