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Bristol Myers Squibb
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Specialist II, IT Validation Services

Specialist II, IT Validation Services

Bristol Myers Squibb

2 - 4 years

4 - 6 Lacs

hyderabad

Posted:None| Platform:

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Skills Required

computer system validation change management sap pharma test management clinical trials agile data integrity data privacy sdlc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position Summary

The role supports the execution of Computer Systems Validation (CSV) activities for systems and applications within the Pharma GxP environment, under the guidance of the Validation Lead or Manager. The individual will collaborate with cross-functional teams and peers across BMS to ensure compliance with CSV standards and regulatory requirements.

Key Responsibilities

Support execution of CSV activities for applications across multiple GxP business areas 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 to 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 bachelor s 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): SAP, ServiceNow, Veeva, 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 and Understanding (desirable) of Electronic Records and Electronic Signature regulations, Data Integrity principles, GAMP and Agile methodologies.

Works predominately within established procedures and 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.

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Specialist II, IT Validation Services