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Job details
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NATURE OF JOB
Hybrid — WFH / WFO / CW
- CATEGORY Programming
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SALARY RANGE
Best in the industry Annual
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EXPERIENCE
1 – 3 Years
- JOB TYPE Full Time
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REGIONAL PREFRENCES
India
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NO. OF VACANCIES
1
Job description
Job Description
< u>< strong>105,000 people reimagining medicine for more than 750 million people globally. That is also the number of people you may impact as our new internal consultant.
POSITION PURPOSE:
The eCompliance Sr. Specialist Specialist 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.
Sr. eCompliance Specialist provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations, etc.. Provides the guidance to the project team on the CSV related topics and related information. Reviews and or approves the global Computerized Systems key validation results as a part of the eCompliance support to the GxP projects
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
< u>< strong>105,000 people reimagining medicine for more than 750 million people globally. That is also the number of people you may impact as our new internal consultant.
POSITION PURPOSE:
The eCompliance Sr. Specialist Specialist 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.
Sr. eCompliance Specialist provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations, etc.. Provides the guidance to the project team on the CSV related topics and related information. Reviews and or approves the global Computerized Systems key validation results as a part of the eCompliance support to the GxP projects
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
- 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.< li>
- Point of Contact for all CSV related matters for GxP Global 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.< li>
- Review and approve project related documents for Global GxP relevant systems including determination of GxP applicability for all Global GxP and non-GxP relevant systems.< li>
- Establish positive relationship with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.< li>
- 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.< li>
- Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within AQWA Q. Provides audit support as assigned and in case of CAPAs, provides the required Quality support.
< li> < ul> Minimum Requirements
< u>< strong>What you’ll bring to the role:- Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent with 5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance.< li>
- Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.). Good experience in the development, implementation and lifecycle management of computerized systems in regulated environments.< li>
- 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.).< li>
- Experienced in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space. Successful cross-divisional functional work with complex international teams.< li>
- Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude. Ability to optimally interact and present to Management. Ability to influence without hierarchical authority and build positive relationships.< li>
- Self-starter with experience in initiating and delivering projects and processes. Excellent communication, negotiation, facilitation, and interpersonal skills.
< li> < ul>Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https: talentnetwork.novartis.com network
Division
< strong>CTS
Business Unit
< strong>NBS QUALITY
Country
< strong>India
Work Location
< strong>Hyderabad, AP
Company Legal Entity
< u>< strong>Nov Hltcr Shared Services Ind
Functional Area
< strong>Quality
Job Type
< strong>Full Time
Employment Type
< strong>Regular
Shift Work
< strong>No
Early Talent
< strong>No < div>< body>< html>
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