Specialist Quality Operations
Specialist Quality Operations
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Job Description
About the job
Summary
Manages Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
About The Role
Major accountabilities:
- Key Performance Indicators
- 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 predefined 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.
- 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 of service deliverables
- Generate and analyze predefined and adhoc reports in various applications (such as AGILE PLM AQWA etc.) and perform followup 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
Minimum Requirements
- Work Experience:
- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring .
- Collaborating across boundaries.
- cleanliness zones.
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future.
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Remote Work :
No
Employment Type
Full Time
