Summary
Provide quality support in compliance with cGMP requirements and Novartis Quality Management System. Manage Quality aspects & projects within area of responsibility.
About the Role
Major accountabilities:
Have expertise in Supplier Quality management and QMS activities. Drafting of QRA, QAA and AMR documents. Handling Supplier Qualifications and change notification.
Interpret and compile APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
Create and review GxP documents including SOPs, working procedures, trend reports, qualification
reports and technical investigations, as and when needed.
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• Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports
• Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality
Operations services in support of product quality compliance and regulatory workflows
• Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure
appropriate execution of service deliverables
• Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required
• Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed
product quality standards and service level agreements
• Support implementing service quality and process improvement projects, CAPA management within
Quality Service Centers
• Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket
management tools and other internal systems and processes
Requirements for the role
- Minimum 6 years of experience in Quality assurance activities in pharmaceutical company.
- GxP knowledge, Basic IT knowledge
- Good communication, presentation and interpersonal skills
- Experience of working closely with the global stakeholders
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- Gmp Procedures.
- Qa (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
Languages :
- English.
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Division
Operations
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No