Sr. Quality Assurance Analyst
Location: Wayne, PA
Salary: 80000 - 90000 + 7% bonus
Responsibilities
* Determines and implements Validation and test strategies for both local
and global SAP projects as well as non SAP 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 corporate 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.
* 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
* SAP experience required
* Must have experience with all aspects of validation documentation
including Validation plan, Risk Assessment, IQ, OQ, PQ, data migration
protocols, Test Plan, Test Report and Validation report
* Must be knowledgeable with all aspects of SDLC (Systems Development Life
Cycle).
* Thorough knowledge of the Code of Federal Regulations, GxPs, FDA & EMEA
regulations governing validated applications including 21CFR Part 11 a must.
* 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
Please visit our website at www.itechcp.
com for more information about our
company and a list of our jobs.
John Barry
ITech Consulting Partners
30 Church Hill Road
Newtown, CT 06470
203-270-0051 Ext: 301
203-270-0071 Fax
john@itechcp.com
www.itechcp.com
Providing IT professionals on a contract or fulltime basis.
Please visit our website at www.itechcp.com for more information about our
company and a list of our hot jobs.
linkedin profile:
http://www.linkedin.com/in/itechjohn
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