Quality Specialist At AstraZeneca Egypt
Key Areas of Responsibility:
Primary point of GMP&GDP contact for the country and maintains an effective governance structure to ensure oversight of quality activities.
Support in providing GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across NEMAG markets.
Supports the development, deployment and monitoring of the GMP/GDP policies and standards and execution in country markets (NEMAG). Providing the assurance that local Quality manual is up-to-date and aligns with global standard requirements.
Partners with cross functional teams to support QMS processes within NEMAG MC, QMS processes includes but not limited to the following:
Audits and Inspection process
Complaint management process; including temperature excursions events quality assessments
Deviation/CAPA/Change control management process
Document management process
Third Party (e.g. Distributor/LSP) management process
Issue Management, including Recalls, Returns & Destruction
Quality Risk Management
GMP/GDP Training Management process
Supports in the evaluation and coordination of any in country (NEMAG) in the pack conversion, repacking and over-labelling activities with the goal to ensure supply and distribution of quality products to the respective markets.
Supports Quality Manager for NEMAG Affiliate Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Leadership. Identify any quality or compliance trends, risks and mitigation actions appropriately.
Represents Quality on cross-functional and cross teams related to NEMAG MC.
Support the implementation of global standardization, simplification and improvement of Affiliate Quality business processes.
Provide training and coaching for Quality network especially GMP/GDP roles.
Participates in strategy and regional objectives setting for the Affiliate Quality organization
Supports Quality Manager in the planning, reviewing and managing the budget for the NEMAG Affiliate Quality organization
Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GxPs.
Accountable for Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batched, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ license to operate.
Responsible for Affiliate GMP&GDP input into divestments/acquisitions/licensing agreements in country
Keeps own knowledge of best practices, industry standards and new developments in quality management up to date
Responsible for managing Quality Standards and expectations across a broad range of services in order to provide a high quality, timely and cost-effective service
Responsible for ensuring that policies and standards meet regulatory requirements
Responsible for country preparation for Regulatory Agency and AstraZeneca inspections/audits and responses
Supports local NEMAG MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation effective self-assessment programs in the country of responsibility.
Responsible for ensuring QMS compliance and continuous improvement in the NEMAG and all issues are adequately managed, and closed on time, risks are identified and escalated to Global Quality.
Promotes a Quality Culture in NEMAG.
Collaborates with cross functional team in the monitoring and achievement of NEMAG country KPIs and objectives/Quality Plans. Ensures country trends are addressed through development of country continuous improvement plans.
Support in ensuring the establishment and maintenance of business continuity plan.
Adheres to Good Manufacturing Practice and Good Distribution Practice, and also ensures regulatory compliance
Jobholders are directly involved with/lead working groups, teams, and projects to proactively provide a global perspective and to drive consistency and standardization in all matters related to quality
Minimum Criteria, Competencies & Personal Attributes:
University Degree level or equivalent
Experience of Good Manufacturing Practice and Good Distribution Practice.
Experience in pharmaceutical Quality environment
Understanding of multiple aspects of physical plant, technical equipment and other elements of facilities management
Strong communication and influencing skills
Project Management
Ability to work independently and in project settings to deliver objectives.
Good command of English Language spoken and written
French Language is an addition
Closing Date:28-August 2023