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Country Quality specialist MTA & Levant Countries



Quality Assurance
Posted on Friday, May 26, 2023
Job Purpose :
Supports the Novartis Country Quality Head of MTA (Morocco, Algeria & Tunisia) and the Novartis Country Quality Head of Levant countries (Lebanon, Jordan, Palestine, Iran, Iraq, Syria) to manage Quality aspects and projects within area of responsibility.
Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.

Major Activities :
- Support NCQ heads to conduct GxP monitoring on all sections, conduct QA investi-gation for non Compliance, Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion. Follow up the correc-tive actions. Archive relative documentations.
- Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
-Contribute to maintain a good Quality system, an updated Master documentation list and updated local SOPs in accordance with Global ones.
- Ensure that all aspects of the handling and distribution of pharmaceutical products in the countries comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
- Ensure that a local Quality System and Standard Operating Procedures are in place for all cGMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.
- Handle GxP deviations on the system and outside (opening, investigation, CAPAs, follow-up…)
- Ensure that Change requests, are managed according to the Novartis SOPs from re-ceipt, through to the implementation and closure.
- Maintain current knowledge of local and international regulatory and legislative re-quirements and trends to ensure that technical support on all quality related matters is provided to the countries in scope.
- Establish a good working relationship with the Supply Chain Management (SCM), DRA and Medical departments.
- Ensure that coordinated contact is maintained with the Regulatory Authorities, the lo-cal partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
- Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with lo-cal/international regulations.
- Ensure that an effective Change Control process is in place.
- Support launches of product in close collaboration with BD& L partner and/ or devel-opment organization.
- Manage complaints, recalls, counterfeits and product tampering according to the No-vartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required.

Key Performance Indicators :
- No overdues and green Quality KPIs
- Local GMP/GDP Quality System in place and continuously updated, as required
GMP/GDP risks proactively identified and effectively mitigated
- The number and severity of GMP/GDP issues identified during internal
and external audits
- Good Quality documentation and updated Master Documentation list
- Robust investigations and well described deviations, GxP Quality events…
-Good support and follow-up of CAPAs and projects