7.0 - 15.0 years

0 Lacs

hyderabad, telangana

On-site

As an eCompliance Manager at Novartis, your role involves providing Quality Assurance oversight and guidance regarding computerized systems validation (CSV) within the framework of regulations such as GxP, 21CFR11, and other relevant requirements outlined in the Novartis Quality Manual and global procedures. Key Responsibilities: - Oversight of operational activities of GxP systems including managing changes, periodic reviews, and deviations - Providing necessary support to ensure compliance with Novartis and regulatory requirements for GxP regulated computerized systems projects - Acting as the main point of contact for all CSV related matters for GxP Computerized Systems and bridging the g...

Posted 2 weeks ago

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Sr. eCompliance Specialist Sandoz

5.0 - 10.0 years

5 - 10 Lacs

hyderabad, telangana, india

On-site

Quality oversight of Project and 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. Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems. Establish trusted partnership with assigned IT Function with unders...

Posted 1 month ago

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PMO-IT Havells India Ltd

8.0 - 12.0 years

0 Lacs

noida, uttar pradesh

On-site

As a Process & Administrative Support professional, you will be responsible for providing operations, tooling, and logistics support. Your role will involve ensuring data protection compliance, maintaining the confidentiality and integrity of data, and generating reports for program/project status reporting. You will also be required to implement governance standards, track project deliverables, and lead the IT quality team in driving quality strategy implementation. Additionally, you will be responsible for creating/publishing project updates, facilitating meetings, managing issues and risks, maintaining deliverables repository, and overseeing workplan management. Your role will also involv...

Posted 3 months ago

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It Quality Analyst Progressive Infovision (PIPL)

2.0 - 7.0 years

1 - 3 Lacs

Noida, Greater Noida

Work from Office

The IT Infrastructure Ticket Quality Analyst is responsible for monitoring, evaluating, and improving the quality of IT support tickets logged and resolved by the service desk and infrastructure teams. Immediate Joiners .

Posted 4 months ago

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Specialist - IT Quality Amgen Inc

7.0 - 12.0 years

9 - 14 Lacs

Hyderabad

Work from Office

What you will do In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for quali...

Posted 4 months ago

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Compliance Specialist Manpowergroup Services India

6.0 - 11.0 years

16 - 30 Lacs

Hyderabad

Work from Office

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle ...

Posted 5 months ago

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