Sr. Ecompliance Specialist

10-15 years

Not Disclosed

Hyderabad

10 Jan. 15, 2025

Job Description

Job Type: Full Time Education: B.E./BCS 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-10035976
Location: Hyderabad, Telangana, India
Posted on: January 8, 2025
Employment Type: Full-time, Regular

Role Summary:

The Sr. eCompliance Specialist plays a critical role in overseeing and ensuring compliance with Quality Assurance (QA) and regulations concerning computerized systems validation (CSV). This role is vital for maintaining GxP standards within the Novartis framework and supporting GxP regulated computerized system projects.

Key Responsibilities:

Operational Quality Oversight:
- Ensure GxP systems are compliant with regulatory requirements (e.g., GxP, 21CFR11, etc.).
- Approve and manage GxP changes, periodic review reports, deviations, and other key documents.
- Support project and operational teams in CSV-related matters.
Documentation and Audit Readiness:
- Maintain documentation for eCompliance and CSV requirements, ensuring it is audit-ready.
- Assist in audits and inspections, ensuring no delays or issues in document presentation.
GxP Changes and CAPA Management:
- Review and approve GxP changes and deviations, ensuring CAPA implementation.
- Monitor gaps within the CAPA Management System and provide the required support.
Collaboration with IT and Business Teams:
- Serve as the main point of contact for all CSV-related matters for GxP systems.
- Foster trusted relationships with IT teams to ensure operational support and business alignment.
Supplier Qualification and Vendor Management:
- Perform supplier qualification assessments and contribute to the supplier management process.
Continuous Improvement:
- Identify gaps in eCompliance and CSV activities, escalate issues, and support the development of mitigation plans.
Support in Validation Master Plan (VMP) Development:
- Contribute to the preparation and execution of VMP for respective systems and functions.

Essential Requirements:

Experience:
- 10–15 years of overall IT experience, with at least 7 years in regulated functions within the pharmaceutical industry (IT Quality, Compliance).
- In-depth knowledge of CSV, 21CFR11, and GxP compliance in regulated environments.
Skills and Expertise:
- Strong knowledge of global regulatory standards and Health Authority expectations.
- Extensive experience managing GxP solutions, including ERP/SAP, MES, LIMS, CRM, IAM, and cloud platforms.
- Understanding of IT system management approaches (ITIL, ITSM) and industry best practices.
Problem-Solving and Project Management:
- Proven ability to manage multiple priorities and shifting demands while maintaining focus and a positive attitude.
- Strong self-starter with the ability to drive and deliver projects effectively.
Communication and Stakeholder Engagement:
- Excellent interpersonal skills, with the ability to communicate, negotiate, and influence effectively across various levels.
- Ability to build and manage relationships with key stakeholders and foster trust within cross-functional teams.

Why Novartis?

Novartis is committed to making a difference in the lives of patients and fostering a collaborative, inclusive work culture. The company offers opportunities to contribute to breakthrough healthcare innovations.

Benefits and Rewards:
Explore benefits designed to support both your personal and professional growth through our Life Handbook.

Diversity and Inclusion:
Novartis fosters an inclusive work environment where diverse teams thrive.

Accessibility:
If you need accommodation due to a medical condition or disability, contact diversityandincl.india@novartis.com for support during the recruitment process.

Division: Operations
Business Unit: Innovative Medicines
Functional Area: Quality
Location: Hyderabad, Telangana, India

Contribute to quality and compliance in GxP computerized systems. Apply Now

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Sr. Ecompliance Specialist

Job Description

Sr. eCompliance Specialist

Role Summary:

Key Responsibilities:

Essential Requirements:

Why Novartis?

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