- Hong Kong Hong Kong
Novartis Pharmaceuticals (HK) Ltd Hiring! Full Time QA Specialist QMS Support in Hong Kong - Ricebowl
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Job Description
Responsibilities
Job Description
Major Accountabilities:
Support product release to the market and ensure compliant to registered version
Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting
Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner
Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual
Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality.
Contributes to an improvement of current processes and/or to an implementation of modified processes.
Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate.
Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments
Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation
Supports Compliance review of projects and inspection readiness and management
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Key Performance Indicators:
Quality standards are understood, designed into work activity, and achieved.
In accordance with departmental objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections
Work Experience:
Quality Management Systems
GxP Experience
Quality Compliance
Quality Assurance
Technological Expertise
Skills:
Dealing With Ambiguity
Decision Making
Project Management
Risk Management
Collaboration
Regulatory requirements knowledge
Problem Solving Skills
Leadership
Communication skills
Data Integrity
Digital saviness
Languages:
English.
Full-time
Major Accountabilities:
Support product release to the market and ensure compliant to registered version
Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting
Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner
Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual
Manages processes and systems for all GxP Quality Assurance e.g. Change control, Training Management, Escalation Management, Risk Management. Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality.
Contributes to an improvement of current processes and/or to an implementation of modified processes.
Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate.
Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments
Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation
Supports Compliance review of projects and inspection readiness and management
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Key Performance Indicators:
Quality standards are understood, designed into work activity, and achieved.
In accordance with departmental objectives such as support of projects with agreed quality and delivery date, passing of internal and external inspections
Work Experience:
Quality Management Systems
GxP Experience
Quality Compliance
Quality Assurance
Technological Expertise
Skills:
Dealing With Ambiguity
Decision Making
Project Management
Risk Management
Collaboration
Regulatory requirements knowledge
Problem Solving Skills
Leadership
Communication skills
Data Integrity
Digital saviness
Languages:
English.
Full-time
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