Sr. Ecompliance Specialist

5-10 years

Not Disclosed

India

10 Nov. 27, 2024

Job Description

Job Type: Full Time Education: None 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

Senior eCompliance Specialist

Location: India
Job ID: REQ-10026554
Company: Novartis Healthcare Private Limited
Functional Area: Quality
Job Type: Full-time

About the Role

The Senior eCompliance Specialist is responsible for overseeing and guiding the Quality Assurance of computerized systems validation (CSV) within regulated environments (e.g., GxP, 21CFR11). This role supports GxP projects and ensures that systems meet the required regulatory standards while providing operational support and guidance for eCompliance matters.

Key Responsibilities

Quality Oversight & Support:
- Provide oversight of GxP systems such as changes, periodic reviews, and deviations.
- Act as the primary point of contact for CSV matters, collaborating between IT and business functions on GxP computerized systems.
Approval & Documentation:
- Review and approve project-related documents for GxP systems.
- Approve deviations, ensuring proper CAPA (Corrective and Preventive Actions) implementation.
- Contribute to the creation of Validation Master Plans (VMP) and execute plans for systems.
Audit & Compliance:
- Support internal and external audits and provide guidance on CAPA management.
- Ensure all documentation related to eCompliance and CSV is up-to-date and audit-ready.
Supplier Qualification & Risk Management:
- Perform supplier qualification assessments for systems and services.
- Identify gaps in eCompliance and CSV activities, working proactively to mitigate risks.

Key Performance Indicators

GxP systems are developed, implemented, and maintained according to Novartis requirements.
Timely approval of changes, deviations, and periodic review reports.
Documentation for eCompliance and CSV is maintained and can be presented during audits.
Proactive identification of eCompliance gaps with supportive mitigation plans.

Minimum Requirements

Experience: 5-10 years of overall experience, with at least 4 years in regulated functions such as IT Qualityand Compliance within the pharmaceutical industry.
Skills:
- Strong understanding of global regulations (CSV, Part 11, etc.).
- Experience in the development, implementation, and lifecycle management of GxP systems.
- Knowledge of ITIL and ITSM for system application management.
- Ability to work cross-functionally with global teams.
- Strong communication, negotiation, and interpersonal skills.

Education

Degree in Information Technology, Life Sciences, Pharmacy, Engineering, or equivalent.

Why Novartis?

Novartis aims to reimagine medicine to improve lives. The company values collaboration and innovation, driven by a diverse team working to achieve breakthroughs that transform patients' lives.

Benefits and Rewards

Explore the benefits in the Novartis Life Handbook: Novartis Life Handbook.

Join the Novartis Network

If this role isn't right for you, stay connected to hear about future opportunities: Novartis Talent Network.

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Sr. Ecompliance Specialist

Job Description

Senior eCompliance Specialist

About the Role

Key Responsibilities

Key Performance Indicators

Minimum Requirements

Education

Why Novartis?

Benefits and Rewards

Join the Novartis Network

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