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Bristol Myers Squibb
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Senior Specialist

Senior Specialist

Bristol Myers Squibb

4 - 6 years

6 - 8 Lacs

hyderabad

Posted:13 hours ago| Platform:

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Skills Required

computer science remediation sap edc test management problem management clinical trials data integrity data privacy recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us .

Key Responsibilities

Functional and Technical

Participate in CSV activities for applications across multiple GxP business areas to ensure fit for use before release to production environment.
Participate in Qualification activities as it relates to infrastructure applications and hardware in a timely manner.
Be part of the team that Conducts risk impact assessments to determine the extent of validation and qualification requirements.
Implementation of organizational IT controls in accordance with applicable regulations and internal procedures.
Author CSV deliverables including but not limited to Plans Summary Reports.
Support the SLC process as it relates to application validation and infrastructure qualification.
Identifies opportunities for simplification, automation for CSV activities and partners with IT Delivery teams and IT Quality to implement.
Supports inspections and audits (internal and external ).
Conducts periodic reviews to ensure applications remain in a state of compliance.
Participates and represents IT Validation Services in problem management and audit remediation activities.
Provides regular status updates to one up manager and escalates any potential issues in a timely manner.

People Management:

Support CSV staff across defined GxP business unit applications to ensure fit for use before release to production environment.

Qualifications Experience

B. E. /B. Tech. or equivalent in computer science, engineering, life science field.
A minimum of 4-6 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projects.
Experience validating one or more of the following systems (desirable): CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, eDC, Regulatory Submission systems.
General knowledge 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.
Good understanding (mandatory) of Electronic Records and Electronic Signature regulations, Data Integrity principles and GAMP methodology.
Works predominately within established procedures. Ability to make decisions that impact own work and other groups/teams and works under minimal supervision.
Demonstrates openness to learning and developing. Takes a responsibility for their own development and growth.
Excellent English verbal and written communication skills including the ability to write clear and precise documentation and deliver articulate presentations.

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Bristol Myers Squibb

Pharmaceutical Manufacturing

Lawrence Township NJ

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Senior Specialist