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 Agreements and that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
• 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 fashion.
• 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 ovide latest know how in the field of GxP and other quality related fields.
• 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.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt

Key performance indicators:

• Local GMP/GDP Quality System in place and continuously updated, as required
• GMP/GDP/Data Integrity risks proactively identified and effectively mitigated.

Minimum Requirements:
Work Experience:

• Prior experience in GxP areas, ideally managing Quality Management Systems.
• Functional Breadth.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills:

• Change Control.
• Continuous Learning.
• Dealing With Ambiguity.
• Product Release.
• QA (Quality Assurance).
• Quality Management.
• Regulation.
• Risk Management.
• Self Awareness.
• Technological Expertise.

Languages :

• English.