Quality Specialist Jobs Opening in Novartis Healthcare Pvt Ltd at Hyderabad
FEATURED JOBR&D Quality Specialist
organization.
Job Description
Quality specialist - level 4 - Z7, 12 months
Job Profile Summary
Lead smaller and less complex projects, while supporting complex initiatives under guidance. Execute higher-complexity routine tasks, including deviation investigations and change controls. Manage projects and processes in line with agreed timelines to support departmental objectives. Ensure compliance with cGMP within TRD.
Job Description
Major Accountabilities:
Provide support and/or deliver services within the designated area of responsibilities, either independently or as part of the team. Provide functional expertise to TRD line functions and other QA units as needed
Author, review, and approve GMP-relevant deliverables to ensure compliance with cGMP & project related quality requirements.
Manage project-related activities to establish or enhance processes, develop tools, and implement quality-related initiatives.
Contribute to projects as an active project team member.
Provide GMP-related support to TRD line functions within the designated area of responsibility.
Ensure compliance with internal and external quality and safety requirements (e.g., Quality Manual, cGMP, health authority guidance, Novartis procedures).
Support and drive the implementation of Novartis QMS within TRD.
Key Performance Indicators:
In accordance with departmental objectives such as support of projects/processes with agreed quality and delivery dates, passing of internal and external inspections.
Maintain sound working relationships with partners and customers.
Meet quality and timelines in area of responsibility.
Feedback from team members, stakeholders and managers.
Act in accordance with Novartis standards in particular; cGMP, ethical, health, safety and environment (HSE), and information security (ISEC)
The number and severity of issues identified during inspections and internal audits.
Role model Novartis culture, values & behaviors.
Work Experience:
Quality compliance & Quality Management Systems (GxP; strong GMP focus)
Deviation Management
Change Control Management
SOP (Standard Operation Procedure) Management
Drug development / R&D exposure (preferred)
Skills:
Business Partnering
Operational Excellence
Collaboration
Regulatory requirements knowledge
Dealing with ambiguity
Problem Solving Skills
Leadership
Communication skills
Data Integrity
Digital savviness
Languages:
English.
Education (minimum/desirable):
Masters
Bachelor/Technician (> 5 years in pharma industry)
