Specialist - Quality Operations

Summary

Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility.

About The Role

Major accountabilities:

• Coordination and management of analytical method transfers and stability studies. Compilation of data reports
• Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
• Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc
• SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
• Validate spreadsheets
• Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
• Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc
• Trend and report all QMS elements as per the request
• Monitor, trend and report Health Safety and Environmental parameters
• Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
• Perform activities of a Quality Control expert as defined by the respective sites
• Support regulatory requirements – routine queries, Chromatogram requests
• Compile Quality performance management decks
• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed
  
  

Key Performance Indicators

• On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration
  
  

Minimum Requirements

• Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
• Min 5 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
• GxP knowledge, Basic IT knowledge
• Good communication, presentation and interpersonal skills
• Experience of working closely with the global stakeholders
  
  

Skills

• Analytical Method Development/ Method Validations/Method Transfers
• Quality Control / In-process / Raw materials /
• Stability studies / Supportive stability studies
• Investigations like OOS/OOE/OOT
• Pharmacopoeia / Health Authority / Regulatory requirements
• GxP / Data Integrity / Quality and Compliance.
• SAP/HPLC/UV
  
  

Languages

• Fluent in English (written and spoken)
  
  

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