The Manager, Validation and Testing will be responsible for ensuring the Digital Manufacturing 4.0 agile teams are compliant with the Pfizer Agile Software Delivery lifecycle and will implement the lifecycle and change management processes. The candidate will formulate and execute on the testing/validation strategy including the manual and test automation for the solutions. The candidate will contribute to the creation of a standardized approach to validation and test automation across the Digital Manufacturing 4.0 teams.
How You Will Achieve It
Ensure full adherence to Agile framework and the Software Development Lifecycle Management working closely with the Product owners, Scrum Masters and Development team
Co-own and conduct the Solution Risk profile assessments, Electronic Record and Electronic Signature (ERES), Data Integrity and Supplier Control Assessments for the M4.0 solutions.
Create and maintain testing/ verification strategy for the M4.0 applications.
Manage execution of Functional Testing, Database Verification Testing, Performance Testing, UAT Testing etc., to ensure the solution meets business needs.
Manage the testing defects triage process and track defects to closure.
Develop and implement the test automation framework using the Pfizer preferred testing tools
Execute the Release Management Process to ensure compliant release of applications to production.
Partner with and support the Business Users during the User Acceptance Testing and obtain business sign off for Release
Create the software quality deliverables such as user requirements, test protocols, testing traceability matrix and test summary report
Facilitate and execute on the software change management process for the deployment of the applications into different Environments.
Support Disaster Recovery Planning & Testing
Support AC&D (Acquisitions, Collaborations & Divestitures)
Support Inspection Readiness and Regulatory Board(s) Audits, as required
Qualifications
Must-Have
Education: Bachelor’s Degree
5+ years of relevant experience
Experience with Agile Software Delivery
Strong process and procedure skills, most particularly regarding System Development Lifecycle and functional enhancement governance
Ability to work across multiple concurrent activities and successfully adapt to changing priorities as required.
Must have strong analytical skills, excellent verbal, and written communication skills, be detail-oriented, self-directed, and a team player.
Strong experience in MS Office Products (i.e. MS Word, Excel, PowerPoint, Access)
Nice-to-Have
Experience leading GxP compliance for large scale solutions (e.g. Manufacturing or Engineering Solutions) in a Pharmaceutical company
Thorough understanding of 21 CFR Part 11
Experience in the use of test management and test automation tools
Experience with Agile Software Delivery and/or Scrum Master Certification a plus.
Experience with Agile Software Delivery and/or Scrum Master Certification
Knowledge of the pharmaceutical industry, preferably Commercial or sales and marketing
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