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Bristol-Myers Squibb

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3.9

based on 134 Reviews

74 Bristol-Myers Squibb Jobs

Specialist II, IT Validation Services

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

3.9

based on 134 Reviews

2-4 years

Hyderabad / Secunderabad

1 vacancy

Specialist II, IT Validation Services

Bristol-Myers Squibb

posted 19d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy SAP CO Artificial Intelligence Information Technology Change Management Test Management

+ 4 more

Job Description

Position Summary

Supports the execution of Computer Systems Validation (CSV) activities for systems and applications in Pharma GxP space under the guidance of Validation Lead/ Manager. Collaborate with peers across BMS on CSV activities.

At BMS, digital innovation and Information Technology are central to our vision of transforming patients lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care.

If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

Key Responsibilities

Functional and Technical
Support execution of CSV activities for applications across multiple GxP business areas the to ensure fit for use before release to production environment
Support execution of Qualification activities as it relates to infrastructure applications and hardware in a timely manner
Support validation lead in conducting risk & impact assessment to determine the extent of validation and qualification
Author CSV deliverables including but not limited Plans & Summary Reports
Support the SDLC process as it relates to application validation and infrastructure qualification
Review and approve change tickets for applications and ensure alignment with change management process.
Conducts periodic reviews of applications to ensure applications remain in a state of compliance.
Provides regular status updates to one up manager and escalates any potential issues in a timely manner

Qualifications & Experience
Minimum Bachelors degree and 2-4 years of experience in IT Quality, Computer System Validation and/or related field.
Experience supporting validation of one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, eDC, Regulatory Submission systems
Experience in change management process
General knowledge (desirable) of IT applications, IT infrastructure, architecture of computer systems including cloud as well as networks, operating systems, databases, and software tools
Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space-and good working knowledge of test management tools like ALM etc.
Familiarity with test automation tools desirable
Understanding (desirable) of Electronic Records and Electronic Signature regulations, Data Integrity principles, GAMP and Agile methodologies
Works predominately within established procedures
Ability to work under minimal supervision
Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth
Good English verbal and written communication skills including the ability to write clear and precise documentation