Senior Specialist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

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

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

Skills

CSV

GxP

Validation

Qualification

Risk Assessment

Impact Assessment

IT Controls

SLC

Audit Support

Periodic Review

Computer System Validation

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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