Manager - Validation And Testing
3 weeks ago
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
- Coown 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 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 ACD (Acquisitions Collaborations Divestitures)
- Support Inspection Readiness and Regulatory Board(s) Audits as required
Qualifications
MustHave
- Education: Bachelors 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 detailoriented selfdirected and a team player.
- Strong experience in MS Office Products (i.e. MS Word Excel PowerPoint Access)
NicetoHave
- 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
Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech data science and IT domains.
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Remote Work :
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