Quality Expert At Novartis Pharmaceuticals
-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 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.
- 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 BD& 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 part.
- Ensure that all aspects of GxP Third Party Operation are compliant with the requirements of Novartis Quality Policies and meet all relevant GxP regulatory and legislative requirements.
-Managment of Quality agreement, Qualification & Oversight in addition to inspections and Audit of Warehouse Third Party and ensure relevant CAPAs have been completed- as relevant.
- Ensure that a local QS and SOPs are in place for all GxP related activities and that compliance with cGxP regulations is maintained through training and internal audits.
- Follow up & monitor KQIs and assure that gaps are addressed appropriately in order to mitigate risk.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends.
- Establish a good working collaboration with other business partners.
- Ensure readiness for all GMP/GDP regulatory inspections.
- Management of Escalations and non-compliance process as relevant.
- Management of Deviations & Complaints process compliance according to Novartis Corporate Quality Manual and Local written Procedures & ensure Relevant CAPAs have been completed/ closed with trending for improvement.
- Management of Returned Finished Goods.
- Managment of Finished Goods Release to Market/ Distribution and performing Duty of Care, Regulatory Compliance Checks.
-Management of related HA Analysis Requirements/Ref.Std.
- Identify key risks in Regulatory compliance through inspections & self-assessments.
- Management of Artworks- as relevant.
3-5 years of relevant QA experience in a multinational pharmaceutical organization