Job description

Job Description Summary

Job Description

Major Accountabilities:

• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.

  
  
  

• Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self-Inspection schemes for all sections.

  
  
  

• Monitor actions and corrections accordingly.

  
  
  

• Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely manner.

  
  
  

• Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.

  
  
  

• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.

  
  
  

• Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation.

  
  
  

• Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products -Support launches of product in close collaboration with BDand L partner and/ or development organization.

  
  
  

• Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.

  
  
  

• Ensure that coordinated contact is maintained with all parties (the Regulatory Authorities, the local partners and stakeholders and Global QA).

  
  
  

Essential requirements:

• Scientific University Degree.

  
  
  

• +5 years of experience within the Quality Assurance and/or Regulatory Affairs department of a multinational pharmaceutical company.

  
  
  

• Deep GMP/GDP knowledge.

  
  
  

• Strong local and global stakeholder management skills.

  
  
  

• Fluent in English.

  
  
  

Commitment to Diversity & Inclusion

Novartis is a proud member of the ILO Global Business and Disability Network and the Valuable 500, promoting the inclusion of people with disabilities in workplaces around the world. We also collaborate with international partners, such as Disability: IN, Purple Space, and Business Disability Forum to identify and develop best practice solutions to enable people with disabilities to participate as equal members of our organization.

Skills Desired