
Senior GxP Specialist for Computerized Systems
1 day ago
We are seeking a Senior GxP Specialist to join our team in the operational management of GxP solutions. The ideal candidate will have experience in the development, implementation and lifecycle management of computerized systems in regulated environments.
Key Responsibilities:- Quality oversight of Project and operational activities of GxP systems (e.g.: changes, Periodic Reviews, deviations, etc.)
- Point of Contact for all CSV related matters for GxP Computerized Systems
- Review and approve project related documents for GxP relevant systems
- Establish trusted partnership with assigned IT Function
- Review and approve the GxP impacted deviations
- Good understanding of global regulations and Health Authorities expectations governing computerized systems
- Experience in the operational management of GxP solutions including its related technologies
- Successful cross-divisional/functional work with complex international teams
- Ability to adjust to multiple demands and unexpected events
Contribute to the preparation of VMP and execute the plan for the systems associated with the respective functions. Perform supplier qualification assessment activities and provide audit support as assigned.
-
GxP Compliance Expert
1 day ago
Hyderabad / Secunderabad, Telangana, India beBeeGxpComplianceSpecialist Full time ₹ 1,50,000 - ₹ 28,00,000Job Title: GxP Compliance Specialist","","Provide strategic oversight of operational activities for GxP systems including quality management, regulatory compliance and system implementation.","Ensure adherence to Novartis and regulatory requirements for GxP regulated computerized systems projects.","Act as the primary point of contact for CSV related matters...
-
Hyderabad / Secunderabad, Telangana, India beBeeCompliance Full time ₹ 1,04,000 - ₹ 1,30,878Job Description">Overview">Lead the quality oversight of operational activities for GxP systems (e.g., changes, periodic reviews, deviations etc.)Provide support to meet Novartis and regulatory requirements for GxP regulated computerized systems projectsAct as a point of contact for all CSV related matters for GxP Computerized Systems and interface between...
-
GxP Compliant System Manager
5 days ago
Hyderabad, Telangana, India beBeeEcompliancemanager Full time US$ 1,30,000 - US$ 1,85,000Job Description:The eCompliance Manager is responsible for ensuring the quality of computerized systems within the organization. This involves providing Quality Assurance oversight and guidance with regard to CSV operating within the framework of regulations, such as GxP and 21CFR11. The eCompliance Manager also provides operational support in approving GxP...
-
Senior Regulatory Compliance Specialist
3 days ago
Hyderabad / Secunderabad, Telangana, India beBeeRegulator Full time ₹ 9,00,000 - ₹ 12,00,000Job Description:As a key member of the regulatory compliance team, you will play a pivotal role in ensuring the quality and integrity of computerized systems within our organization.Major accountabilities include:Quality oversight of projects and operational activities related to GxP systems, including changes, periodic reviews, deviations, and more. You...
-
Senior Compliance Manager
1 week ago
Hyderabad / Secunderabad, Telangana, India beBeeGxp Full timeAbout this RoleWe are seeking an experienced GxP Compliance Specialist to join our team. The successful candidate will be responsible for ensuring the quality and compliance of computerized systems, including review and approval of project-related documents, determination of GxP applicability, and establishment of trusted partnerships with IT functions.They...
-
Operational Quality Specialist
1 week ago
Hyderabad / Secunderabad, Telangana, India beBeeRegulatory Full timeJob Title: eCompliance ManagerWe are seeking a skilled eCompliance Manager to join our team. As an eCompliance Manager, you will be responsible for ensuring the quality and compliance of operational activities related to GxP systems.Key Responsibilities:Quality oversight of operational activities of GxP systems, including Changes, Periodic Reviews, and...
-
Senior Regulatory Compliance Specialist
1 week ago
Hyderabad, Telangana, India beBeeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Job OverviewWe are seeking a highly skilled eCompliance Specialist to join our team. The ideal candidate will have a strong background in regulated computerized systems and excellent communication skills.ResponsibilitiesProvide quality oversight of project and operational activities related to GxP systems.Ensure that all applicable Novartis and regulatory...
-
Chief GxP Systems Administrator
1 week ago
Hyderabad, Telangana, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 23,00,000Our team seeks a Compliance Manager to oversee the quality and integrity of our GxP systems.Key Responsibilities:Oversight of operational activities related to regulated computerized systemsSupport for compliance with applicable regulations and industry standardsPoint of contact for CSV-related mattersReview and approval of project documents related to GxP...
-
IT Quality Specialist
6 days ago
Hyderabad / Secunderabad, Telangana, India beBeeAssurance Full time ₹ 1,04,000 - ₹ 1,30,878We are seeking a skilled Quality Assurance Manager to lead the execution of complex validation assignments and ensure the compliance of our systems. The ideal candidate will have extensive experience in Software and Systems Quality Assurance, a strong understanding of GxP regulations, and proven expertise in validation methodologies.Key Responsibilities:Lead...
-
Senior Quality Assurance Specialist
6 days ago
Hyderabad / Secunderabad, Telangana, India beBeeQualityManager Full time ₹ 1,04,000 - ₹ 1,30,878Job DescriptionWe are seeking a skilled professional to join our team as a Quality Events and Investigations Manager. The ideal candidate will have extensive experience in quality management, investigation techniques, and regulatory compliance.This role involves defining processes, authoring quality documents, providing training, driving continuous...