Sr Specialist

Bristol Myers Squibb; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Bristol Myers Squibb Hyderabad is seeking an experienced CSV professional to lead validation activities across multiple GxP applications. You will ensure fit-for-use before production, conduct risk assessments, and implement IT controls in line with regulatory requirements.

The role requires 7–9 years in computer systems validation with at least 3 years in CSV project management, plus strong English communication and documentation skills.

Qualifications

• B.E./B.Tech. or equivalent in computer science, engineering, life science field.
• 7–9 years of experience in computer systems validation in the pharmaceutical industry, including at least 3 years managing CSV projects.
• Experience validating systems such as CTMS, eTMF, ServiceNow, Veeva, Qumas, SAP, MES, PV, Regulatory Submission systems.
• General knowledge of IT applications, IT infrastructure, architecture of computer systems including cloud, networks, OS, databases, and software tools.
• Good knowledge of IT testing practices and ALM tools.
• Familiarity with test automation tools.
• Understanding of Electronic Records and Electronic Signature regulations, Data Integrity, and GAMP methodology.
• Strong English communication and documentation skills.

Responsibilities

• Participate in CSV activities to ensure fit for use before release to production environment.
• Participate in Qualification activities related to infrastructure applications and hardware.
• Contribute to risk impact assessments determining validation requirements.
• Implement IT controls in line with regulations and internal procedures.
• Author CSV deliverables including Plans, Summary Reports.
• Support the SLC process for application validation and infrastructure qualification.
• Identify opportunities for simplification and automation with IT Delivery teams and IT Quality.
• Support inspections and audits (internal and external).
• Conduct periodic reviews to maintain compliance of applications.
• Represent IT Validation Services in problem management and audit remediation.
• Provide regular status updates to manager and escalate issues timely.
• Support CSV staff across GxP applications to ensure fit for use before release.

Skills

CSV validation

GxP compliance

Documentation writing

Risk assessment

Problem solving

English communication

Audits support

Team collaboration

Education

B.E./B.Tech. or equivalent in computer science/engineering/life sciences

Tools

CTMS

eTMF

ServiceNow

Veeva

Qumas

SAP

MES

PV

Regulatory Submissions systems

Job description

Responsibilities

• 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
• 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 7-9 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, 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
• 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.