Quality Compliance

Job Description

This is a contract role under ManpowerGroupPurpose/Objective of the jobThe Quality Responsible Person complies with the GDP regulation for the Clients Middle East markets.This role is responsible for ensuring that a quality management system is implemented and maintained, for the distribution activities of products in all middle east markets, aligned both to market regulations as well as global quality framework.Expected area of competence:? Ensures the implementation and maintenance of quality management system, including the documentation and required records.? Deals with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.? Impacts and influences the organization by escalating quality issues and decisions which impact the business.? Ensures compliance of market Third Party Distribution partners to BMS Quality requirements related to distribution and transportation.? Ensures continuous improvement activities for more effective Quality systems across the organization.? Active participation to company business growth objectives for quality alignment.Key Responsibilities and Major Duties:1. Ensure that a Quality Management System is implemented and maintained in the local affiliate, including:? Acts as the local Qualified Person responsible for GDP in accordance with Market regulatory requirements? Maintains Quality System Documentation: procedures and recordso Policy/Directives/SOPs impact assessment and implementationo GDP and Local regulations impact assessment and implementation? Meeting the requirements of the defined Quality Unit activities? Ensures initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified? Develops and maintain locally the Quality Manual? Ensure that relevant customer complaints are dealt with effectively? Performs periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures? Ensures implementation of Deviation and CAPA management? Ensures implementation of the Change Control management? Leads the Quality Management Review/Quality Council of the Market? Implements adequate action plans for metrics achievement when necessary2. Ensures implementation of following Quality Operations:? Dubai HUB quality oversight, including approval of products to the markets as well as ensure export compliant to UAE quality relevant regulations? Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status? Customers oversight: periodic customer verification compliance? Product Quality status and batch release or approval to the market? Local release process? Handles compliance/quality issues with the impacted market team? Attends the market action fact finding meetings when required and defines the adequate action plans within market? Ensures On Hold products request are observed? Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls? Decides on the final disposition of rejected, recalled or falsified products? Approval of the returns to saleable stock, according to BMS requirements? Support Supply Chain to avoid Back Orders? Provide quality input on shortage situations and oversight reporting to Health Authority? Medical samples Quality distribution oversight? Supports of sampling requested by HA (product, procedures, reference substances)? Keeps appropriate records of any delegated duties3. Facilitate that requirements are implemented in the Local Distribution Centre for:? Warehousing facilities (HUB)? Secondary packaging facilities? Transportation processes4. Quality Risk Management? Coordination and preparation of Quality Risk Management? Participate in the periodic Business Review with the local Distribution Centre5. Inspections and Regulatory Surveillance? Maintenance of the Wholesale Distributor License with Regulatory agency? Import certificates, when requested? Support the Global Quality Audits in the market? Preparation of HA inspection in local entity and leading HA inspection? Anticipate the new directives (Regulatory surveillance) and proactively drive change

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