Sr. Ecompliance Specialist

5-10 years

Not Disclosed

Hyderabad

10 March 4, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr. eCompliance Specialist

Job ID: REQ-10037187
Location: Hyderabad, India
Category: Quality
Business Unit: Innovative Medicines
Job Type: Full-time, Regular
Company: Novartis Healthcare Private Limited

Role Summary:

The Senior eCompliance Specialist is responsible for providing Quality Assurance oversight and guidance on computerized systems validation (CSV) while ensuring compliance with GxP, 21 CFR Part 11, and Novartis global quality standards. This role supports operational compliance, approves GxP-related changes, and ensures adherence to validation requirements.

Key Responsibilities:

Quality & Compliance Oversight:

Provide quality oversight of GxP systems, including changes, periodic reviews, and deviations.
Ensure compliance with Novartis and regulatory requirements for GxP computerized systems projects.
Serve as the primary contact for CSV-related matters, acting as a bridge between IT and Business.
Review and approve project-related documents for GxP systems, ensuring GxP applicability.
Establish trusted partnerships with IT teams, providing operational guidance on eCompliance topics.

Operational Support & Documentation:

Review and approve GxP deviations and ensure appropriate CAPA implementation.
Contribute to Validation Master Plan (VMP) preparation and execution.
Review and approve Periodic Review Reports and manage associated gaps through the CAPA system.
Conduct supplier qualification assessments and support audit activities as assigned.

Key Performance Indicators:

Timely review and approval of changes, deviations, and periodic review reports.
Up-to-date documentation supporting eCompliance and CSV requirements for audits.
Proactive identification of compliance gaps and support for mitigation plan development.
Effective stakeholder collaboration with positive feedback from clients and teams.

Qualifications & Experience:

Essential Requirements:

5-10 years of experience, with at least 4 years in the pharmaceutical industry in regulated functions like IT Quality & Compliance.
Strong knowledge of CSV, GxP regulations, and 21 CFR Part 11.
Experience in computerized system development, implementation, and lifecycle management in regulated environments.
Hands-on experience in GxP supplier qualification activities and IT quality support.
Knowledge of ITSM, ITIL, ERP, MES, LIMS, CRM, and infrastructure management.

Desirable Skills:

Ability to work in cross-functional, international teams.
Strong communication, negotiation, and leadership skills.
Ability to handle multiple priorities and shifting demands.
Experience in presenting to senior management and influencing decisions.
Self-starter with a proactive approach to compliance and quality assurance.

Commitment to Diversity & Inclusion:

Novartis is dedicated to fostering an inclusive work environment and providing reasonable accommodations for individuals with disabilities.

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Sr. Ecompliance Specialist

Job Description

Role Summary:

Key Responsibilities:

Quality & Compliance Oversight:

Operational Support & Documentation:

Key Performance Indicators:

Qualifications & Experience:

Essential Requirements:

Desirable Skills:

Commitment to Diversity & Inclusion:

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