Demonstrated ability to construct and expand on a scalable quality management system that is flexible to emerging needs of the global Novartis function. Ability to clone, with modification where necessary, site specific QMS and install in other global service centers within the NBS domain. Use the long-standing professional experience and the well-established knowledge of both the Novartis Quality System and the relevant International Legislation to: oEnsure that all aspects of the operational business comply with cGMP regulatory requirements and the Novartis Pharma Quality Manual and Policies. o Lead the development, implementation and governance of GxP processes, systems and tools that support the PLS vices across divisions. Convincingly represent the commitment of Novartis as company with high quality standards towards GBS Customers o Support the successful implementation of the NBS vision and strategy and the Novartis Quality strategy within PLS M&SO organization.
Salary: Not Disclosed by Recruiter
Industry:Medical / Healthcare / Hospitals
Functional Area:IT Software – Application Programming , Maintenance
Role:Quality Assurance/Quality Control Manager
service development pharma offshore tools quality systems documents policies standards operational
Desired Candidate Profile:
UG: B.Tech/B.E. – Computers
PG:Post Graduation Not Required
Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required
Support all activities related to Quality Oversight Develop and maintain Quality Systems and related processes globally for PLS aligned with Novartis Corporate Quality Manual, Policies and any other legislative requirements. Prepare, review and approve GMP documents incl. local and global SOPs, WPs and/or local Quality Modules, investigation reports etc. Guarantee that the PLS M&SO operational business is in compliance with cGMP, SLAs, regulatory requirements and the Novartis Corporate Quality Manual and is conducted according to the relevant SOPs Identify gaps / deficiencies in the established PLS M&SO quality system and independently trigger, investigate and implement the necessary corrective action in line with current external and internal standards to ensure the continuous evolution of the quality system. Ensure all time readiness for customer audits, create self-audit plans (including data integrity audits), manage audit action plans and follow up on agreed CAPAs. Provide quality mentoring, critical review, trend reports review and facilitation of problem solv-ing to ensure delivery of quality targets for the PLS M&SO services. Initiate and implement quality improvement projects within PLS M&SO organization. Support establishing quality systems for new services, in particular if new setups outside of the fixed processes require changes in the GMP-setup of PLS M&SO. Ensure adequate level of GMP-education, -knowledge & -competence by contributing to the GMP-training and by devising / supporting special quality initiatives Act as an escalation point to stakeholders for major/critical deviation Ensure accurate measurements are in place (Weekly or monthly reporting and KPI’s
Novartis Healthcare Pvt. Ltd.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.