Sr. Analyst, Digital Quality and Governance

Bristol Myers Squibb

3 - 8 years

10 - 14 Lacs

hyderabad

Posted:3 weeks ago| Platform:

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Skills Required

computer science system architecture erp assurance manager quality assurance sap analytical pharma clinical trials healthcare

Work Mode

Work from Office

Job Type

Full Time

Job Description

Ensure adequate and timely quality assurance / regulatory compliance support
Provide support during regulatory agency and third party inspections
Research new technologies, understand existing processes, and reference recognized standards and frameworks
Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.
Identify opportunities for continuous improvement
Adherence to BMS Core Behaviors
Conduct risk & impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programs
Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems
Implement organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements
Review Periodic Review assignments completions for applications in a timely manner
Support responses to application CAPAs and Audits as they relate to health authority investigations and internal audits in a timely manner-in coordination with multiple stakeholder teams

Qualifications & Experience

An accredited degree in Computer Science, Engineering, or a Life Sciences-related field.
Minimum 3 years of experience in Quality Assurance, IT Compliance, or Computer Systems Validation (CSV) within the pharmaceutical, healthcare, or other regulated industries. Relevant internships, academic projects, or certifications are a plus.
Basic understanding of industry regulations such as 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
Interest in developing deeper knowledge of GAMP, Agile methodologies, and Computer Software Assurance (CSA).
Awareness of GxP compliance and its importance in managing electronic records and signatures.
Introductory exposure to enterprise platforms such as: ERP systems (SAP, Oracle), Manufacturing systems (MES, ELN), Veeva Vault-based applications (CTMS, eTMF, RIM), Quality Management Systems (QMS)
Foundational knowledge of IT infrastructure, including SaaS, databases, and basic system architecture is advantageous.
Awareness of IT testing principles in regulated environments.
Eagerness to gain hands-on experience with tools such as HP ALM and ValGenesis.
Fast learner with strong curiosity and commitment to building domain expertise.
Demonstrates initiative, ownership, and accountability for tasks.
Collaborative mindset with the ability to work effectively in cross-functional teams.
Strong communication and organizational skills, with an analytical approach to solving problems.
Professional proficiency in English (reading, writing, and speaking), with the ability to contribute to clear documentation and presentations.

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