Platform Compliance & Qualification Specialist

Newpage; Bengaluru; Remote; INR 1.900.000 - 2.900.000; Teilzeit

Benefits dieser Stelle

People-first culture

Smart collaboration

Work-life balance

Growth opportunities

Competitive compensation

Zusammenfassung

Newpage Solutions is hiring a Platform Compliance & Qualification Specialist to support a global pharmaceutical client. This is a remote, contract role with India-based operations, focusing on qualification, evidence management, and audit readiness across security and developer tooling.

You will work under a Platform Compliance Lead, converting controls into audit-ready documentation and repeatable procedures for engineering teams while engaging with client regulatory interpretations.

Qualifikationen

• Bachelor’s degree in a related field and 5+ years in validated IT/quality roles in life sciences or regulated industries.
• Experience producing audit-ready qualification deliverables and evidence across platforms.
• Ability to document controls, evidence, and regulatory interpretations clearly.

Aufgaben

• Execute qualification and validation activities for platforms and services; create plans, protocols, scripts, records, and reports.
• Maintain requirements traceability matrices linking requirements, risks, controls, and evidence.
• Document how each control operates and how it is evidenced; support risk assessments and platform packages.
• Collaborate with engineering to ensure evidence management and audit readiness across systems.

Kenntnisse

Compliance

Qualification

Documentation

Risk assessments

IT controls

Cloud platforms

Ausbildung

Bachelor's degree in CS/Engineering/Pharma

Tools

Jira

Confluence

ServiceNow

Veeva Vault

Jobbeschreibung

We are hiring Platform Compliance & Qualification Specialists to keep platforms qualified, compliant, evidenced, and inspection-ready while enabling engineering teams to focus on building.

Flexible and remote work

Employee-centric culture

Work-life balance

Generous earnings

Opportunities for growth

PLATFORM COMPLIANCE & QUALIFICATION SPECIALIST

Location: Remote| Type: Contract

About Newpage Solutions

Newpage Solutions is a global digital health innovation company helping people live longer, healthier lives. We partner with life sciences organisations which include, pharmaceutical, biotech and healthcare leaders, to build transformative AI and data driven technologies addressing real-world health challenges.

From strategy and research to UX design and agile development, we deliver and validate impactful solutions using lean, human-centered practices.

We are proud to be a ‘ Great Place to Work®’ certified company for the last three consecutive years. We also hold a top Glassdoor rating and are named among the \"Top 50 Most Promising Healthcare Solution Providers\" by CIOReview. As an organisation, we foster creativity, continuous learning and inclusivity, creating an environment where bold ideas thrive and make a measurable difference in people’s lives.

Your Mission

We are hiring Platform Compliance & Qualification Specialists to be the execution engine of a shared compliance service supporting the Platform Engineering organization of one of the world’s largest pharmaceutical companies—keeping its platforms qualified, evidenced, and inspection-ready so engineering teams can focus on building.

You will work in a dedicated Newpage team, directed by an onshore Platform Compliance & Qualification Lead, delivering qualification activities, evidence management, technical writing, documentation maintenance, recurring control execution, audit readiness preparation, and compliance reporting across security, observability, developer tooling, and future platform initiatives.

This is a hands‑on role for someone who enjoys making compliance concrete: turning control requirements into clear documentation, complete evidence, and repeatable procedures that engineering teams can actually follow. You will work in the client’s systems of record and evidence repositories, to the client’s regulatory interpretation, with the Lead setting strategy and owning stakeholder engagement.

The Three Pillars

• Establish. Design, implement, and evidence the controls needed to qualify platforms and services—qualification and validation planning, control design, supplier onboarding and vendor oversight, SDLC governance and documentation, requirements traceability, risk assessments, evidence collection, and platform qualification packages.
• Sustain. Operate the recurring controls that keep platforms in a compliant state over time—periodic and privileged access reviews, vendor oversight, change management evidence reviews, SLA and operational control reviews, compliance metrics and reporting, and governance support.
• Audit Ready. Maintain a continuously auditable operating environment—readiness assessments and internal reviews, audit package preparation, evidence and documentation management, inspection support, corrective action tracking, and continuous control monitoring.

You will execute across all three pillars. The function is a shared service—it supports platform teams but does not own their engineering delivery—and regulatory interpretation, final positions, and sign‑off remain with the client’s Compliance, Quality, and Legal functions.

What You’ll Do

Qualification and Validation

• Execute qualification and validation activities for platforms and services: plans, protocols, test scripts, execution records, and summary reports.
• Build and maintain requirements traceability matrices linking requirements, risks, controls, and evidence.
• Support control design and implementation with engineering teams; document how each control operates and how it is evidenced.
• Contribute to risk assessments and assemble platform qualification packages.
  

Evidence and Documentation

• Collect, organize, and maintain compliance evidence in the client’s systems of record and evidence repositories—complete, current, and retrievable on demand.
• Write and maintain qualification documentation, support plans, operational procedures, governance documentation, and audit narratives to an audit‑grade standard.
• Maintain knowledge management content so the function’s processes are repeatable and self‑serve for platform teams.
• Support the preparation of regulatory responses.
  

Recurring Control Execution

• Run periodic and privileged access reviews, change management evidence reviews, and SLA and operational control reviews on schedule and to standard.
• Perform vendor oversight activities and support supplier onboarding documentation.
• Produce compliance metrics and reporting for governance forums.

Audit Readiness

• Prepare audit packages; run evidence quality reviews and internal readiness checks ahead of audits and inspections.
• Support gap assessments and control maturity reviews; document findings and remediation plans.
• Track corrective actions to closure and support continuous control monitoring and inspection preparedness.
  

What You Bring

Compliance and Qualification

• 5+ years in computer system validation and qualification, IT compliance, or IT quality within life sciences or another regulated industry.
• Working knowledge of the regulatory and quality frameworks governing computerised system qualification and validation in pharma, with exposure to IT general controls.
• Hands‑on experience producing validation deliverables—plans, protocols, test scripts, traceability matrices, and summary reports.
• Experience executing recurring controls such as access reviews, change reviews, and vendor oversight.
  

Technical Writing

• Excellent written English; able to produce clear, precise, audit‑grade documentation and procedures that a reviewer can follow without you present.
• Comfortable working to documentation standards, templates, and document control processes.
• Enough understanding of cloud platforms, CI/CD pipelines, developer tooling, infrastructure, and identity and access management to document and evidence controls credibly.
• Familiarity with ticketing, documentation, and GRC tooling such as Jira, Confluence, ServiceNow, and Veeva Vault.
  

Foundations

• Based in India and able to provide meaningful overlap with US working hours.
• Organized and detail‑oriented, and comfortable owning a recurring workload with firm deadlines.
• Bachelor’s degree in Computer Science, Engineering, Pharmacy, Life Sciences, or a related field.

Bonus Skills / Experience

• Experience supporting platform or infrastructure qualification, not only application validation.
• Exposure to compliance automation and evidence automation approaches.
• Prior work with large pharma clients through a services or consulting firm.
• Cybersecurity exposure—supporting security controls, access management reviews, or security evidence collection.
• Relevant compliance, audit, or security certifications.

What Success Looks Like

• By 90 days. Onboarded into the client’s tools and evidence repositories, executing recurring controls independently, with your first documentation deliverables accepted first time.
• By six months. Owning qualification deliverables for at least one platform end to end, with the evidence for your scope complete and audit‑retrievable.
• By a year. The person platform teams go to for compliance documentation, contributing templates and accelerators that make the next platform faster to qualify.

What We Offer

At Newpage, we’re building a company that works smart and grows with agility, where driven individuals come together to do work that matters. We offer:

• A people-first culture - Supportive peers, open communication and a strong sense of belonging
• Smart, purposeful collaboration - Work with talented colleagues to create technologies that solve meaningful business challenges
• Balance that lasts - We respect your time and support a healthy integration of work and life
• Room to grow - Opportunities for learning, leadership and career development, shaped around you
• Meaningful rewards - Competitive compensation that recognises both contribution and potential

More about Newpage

Newpage is a digital health solutions company. We devote ourselves to advancing the quality of life by enhancing health and optimizing the longevity of people. We do this by, passionately building futuristic technologies for global organizations across the healthcare ecosystem. We partake at every stage from problem definition, strategy & service design, user research, UX design, and agile software development – utilizing lean practices to deliver and validate highly innovative digital health solutions that drive user value and business transformation.

Newpage is recognized by ‘CIO’s Review’ as“Top 50 Promising Healthcare Solution Providers”andGreat Place to Work Certified (GPTW) 2023 & 2024.