Senior Associate

2 weeks ago

chennai, India Pfizer Full time

Why Patients Need You

Technology impacts everything we do. Pfizer’s digital and ‘data first’ strategy focuses on implementing impactful and innovative technology solutions across all functions from research to manufacturing. Whether you are digitizing drug discovery and development, identifying solutions, or making our work easier and faster, you will be making a difference to countless lives.

What You Will Achieve

The Digital Manufacturing Team is responsible for the delivery of Pfizer’s Core Digital Manufacturing Operations Management (MoM) capabilities at every level of the Pfizer Global Supply (PGS) Plant Network (ISA 95 Levels 0-4). These solutions are critical to Manufacturing & Lab Execution, Manufacturing Process Intelligence and Production Optimization that aim to improve product quality, increase asset utilization/uptime, automate manual workflows, and streamline plant floor operations. The Digital Manufacturing vision is to “Simplify processes and experiences to drive PGS outcomes”.

The Manufacturing 4.0 Team supports all of Pfizer’s Core Manufacturing & Engineering Solutions, while enabling a secure, seamless flow of contextualized data from the device & control levels, all the way to the top of the Enterprise. Our goal is to create persona driven, connected experiences across our shop floors to predict and optimize operations, while providing real-time insights to operators. Come join us to create Pfizer’s Factory of the Future

The Senior Associate, Validation and Testing play a key role in ensuring the Digital Manufacturing 4.0 agile teams are executing on the Pfizer Agile Software Delivery lifecycle and change management practices. The candidate will participate in executing the testing/validation strategy and be responsible for executing the manual and automated test strategy for the M4.0 solutions. The candidate will contribute to creation and execution of a standardized approach to validation and test automation across the Digital Manufacturing 4.0 teams.

How You Will Achieve It

Author and manage the software validation deliverables such as Test Plan, user requirements, test protocols, test scripts, testing traceability matrix and test summary report

Support the Solution Risk profile assessments, Electronic Record and Electronic Signature (ERES), Data Integrity and Supplier Control Assessments for the M4.0 solutions.

Execute on the testing/ verification strategy for the M4.0 applications.

Support and perform the Functional Testing, Database Verification Testing, Performance Testing, UAT Testing etc., to ensure the solution meets business needs.

Find and document application defects during Testing Process and track to closure. 

Develop and maintain automation test scripts using the Pfizer preferred testing tools per the test automation strategy

Support the Business Users during the User Acceptance Testing and obtain business sign off for application release

Support and execute on the software change management process for the deployment of the applications into different Environments.

Support Disaster Recovery Planning & Testing

Support Inspection Readiness and Regulatory Board(s) Audits, as required

Qualifications

Must-Have

Education: Bachelor’s Degree

3+ years of relevant experience

Experience with IT Software Development Lifecycle

Possess expertise on Good Documentation and Good Testing Practices

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 in GxP compliance for IT solutions (e.g. MES or Engineering Solutions) in a pharmaceutical company

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


Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Information & Business Tech#LI-PFE

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