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Merck Sharp & Dohme (MSD)
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Specialist , Technology Compliance

Specialist , Technology Compliance

Merck Sharp & Dohme (MSD)

3 - 5 years

5 - 7 Lacs

hyderabad pune

Posted:1 day ago| Platform:

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Skills Required

business process it risk operational excellence data management information security healthcare life sciences business solutions information technology monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role Overview

We are seeking a mid-level specialist to lead and sustain GMP-compliant SDLC activities for the DataLynx platform and support future validation efforts for SEEQ. This role is critical to ensuring regulatory alignment and operational continuity across quarterly release cycles and long-term system lifecycle management.

Key Responsibilities

Own and execute GMP SDLC deliverables for DataLynx, including validation documentation, testing protocols, and release planning.
Collaborate with cross-functional teams (Quality, IT, Product) to ensure compliance with SDLC-SOP-09 and CSA methodology.
Support periodic validation cycles and change control processes for DataLynx and SEEQ platforms.
Maintain system documentation and configuration profiles in alignment with GMP standards.
Participate in workshops and stakeholder sessions to define validation scope and resource needs.
Contribute to SOP development and lifecycle sustainment for IT system administration and validation packages

Qualifications

Bachelor s degree in Computer Science, Engineering, Life Sciences, or related field.
3 5 years of experience in GMP validation, SDLC execution, or CSV/CSA methodologies.
Familiarity with tools such as Jira, Confluence, and Digital SDLC platforms
Strong understanding of regulatory frameworks (FDA, EMA, ICH) and risk-based validation approaches.
Excellent documentation, communication, and stakeholder engagement skills.

Preferred Skills

Experience supporting validation efforts for manufacturing intelligence platforms.
Knowledge of SDIRA, IT Supplier Management, and automated compliance tools.
Prior exposure to SOP authorship and lifecycle sustainment in a GMP environment.

Required Skills:

Control Monitoring, Data Analytics, Data Management, Digital Manufacturing, Digital Transformation, Documentations, Global Manufacturing, GMP Compliance, Information Security, Information Technology Operations, IS Audit, IT Executive Management, IT Risk Assessments, IT Risk Governance, IT Risk Response and Reporting, Knowledge of regulations and frameworks, Mechatronics, Operational Excellence, Policy and process development, Regulatory Compliance, Regulatory Frameworks, Stakeholder Engagement, Stakeholder Management, Supplier Relationship Management, Technical Advice

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Specialist , Technology Compliance