eCompliance Manager

2 days ago

Hyderabad, Telangana, India Novartis Full time ₹ 8,00,000 - ₹ 12,00,000 per year

Job Description Summary

The eCompliance Manager is responsible for providing Quality Assurance oversight and
guidance with regard to computerized systems validation (CSV), operating within the
framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis
Quality Manual and global procedures.
eCompliance Manager provides the needed operational support such as approving the
GxP impacted changes, Periodic Review Reports, deviations etc., Provides the guidance
to the project and operations team on the CSV related topics and related information.
Reviews and/or approves the global Computerized Systems key validation deliverables
as a part of the eCompliance support to the GxP projects.

Job Description

Major accountabilities:

  • Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic

    Reviews, Deviations etc.,)

  • Provide needed support to meet the applicable Novartis and regulatory

    requirements for GxP regulated computerized systems projects.

  • Point of Contact for all CSV related matters for GxP Computerized Systems and act

    as an interface between IT and Business for eCompliance topics in relation to GxP

    classified Computer Systems promoting a Quality Culture.

  • Establish trusted partnership with assigned IT Function with understanding of

    business drivers, and provide the needed day to day operational support.including

    determination of GxP applicability for all GxP and non-GxP relevant systems.

  • Review and approve the GxP Changes and the associated deliverables.

  • Review and approve the GxP impacted deviations, ensure appropriate CAPA are

    implemented.

  • Contribute for the preparation of VMP and execute the plan for the systems

    associated with the respective functions.

  • Review and approve the Periodic Review Reports for the GxP computerized systems

    and the associated gaps within CAPA Management System.

  • Perform supplier qualification assessment activities.

  • Provide Audit support as assigned and in case of CAPAs, provide the required

    Quality support.

Key performance indicators:

  • GxP relevant computerized systems are developed, implemented and

    maintained according to the Novartis requirements.

  • On time review and approval of changes, deviations & periodic review

    reports for the GxP computerized systems.

  • Documentation supporting eCompliance and CSV requirements is in place,

    maintained up-to-date and can be presented during audits and inspections

    without delays and issues.

  • Gaps in eCompliance and CSV activities are proactively identified, escalated

    and the development of mitigation plans supported.

  • Client/stakeholder satisfaction and corresponding feedback.

Minimum Requirements: Degree in Information Technology, Life Sciences,

Pharmacy, Engineering or equivalent
Work Experience:

  • 10-15 years of overall IT experience, and a

    minimum 7 years of relevant experience in the

    Pharmaceutical Industry and in particular within

    regulated functions such as IT Quality and

    Compliance

  • Solid understanding of global regulations and

    Health Authorities expectations governing

    computerized systems (CSV, Part 11, etc.)

  • Solid experience in the development,

    implementation and lifecycle management of

    computerized systems in regulated environments

  • Experience in quality management of Cloud,

    SaaS platform, mobile and digital application

    used in regulated environments

  • Highly experienced in the operational

    management of GxP solutions including its

    related technologies to support the operation

  • Good understanding in system application

    management, its Quality support approach and

    industry best practices (ITIL, ITSM, etc.)

  • Experience in the development, implementation

    and lifecycle management of key computerized

    systems in the Pharmaceutical Development,

    Manufacturing, Quality, Commercial and

    Infrastructure space (e.g. ERP/SAP, MES, LIMS,

    CRM, IAM, etc.)

  • Successful cross-divisional/functional work with

    complex international teams

  • Experience in GxP supplier qualification activities

  • Proven ability to adjust to multiple demands,

    shifting priorities and unexpected events while

    maintaining a positive work attitude

  • Ability to effectively interact and present to

    Management

  • Ability to manage the key stakeholders and build

    trust

  • Proven ability to influence without hierarchical

    authority and build trusted partnerships

  • Proven self-starter with experience in initiating

    and delivering projects and processes

  • Excellent communication, negotiation, facilitation,

    and interpersonal skills

Skills Desired

Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise

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