KSA Commercial Quality Specialist – Johnson & Johnson Services, Inc (Riyadh, Saudi Arabia)

▪ Manages product quality complaints and adverse events process in liaison with franchise quality team, local commercial team, distributors and brand protection.
▪ Supports and cooperates in the implementation of the Field Safety Corrective Actions (FSCA).
▪ Conducts associated HA reporting to SFDA for product complaints and Field safety corrective actions. Has a good knowledge of health authority regulations for medicovigilance. Supports any other HA inquiries related to safety and efficacy of the product and quality related aspects.
▪ Act as NCMDR Officer to support SFDA communications on behalf of JnJ KSA MedTech.
▪ Conducts supplier and distributor audits; 3PL audits. Tracking of the follow-up activities to address observations after the audits. Work with nonconformities and CAPAs after the audits in the corporate electronic tracking systems.
▪ Supports supply chain/warehouse/loaner kit activities from quality perspective. Executes QA activities in warehouse system (SAP).
▪ Identifies deviations and raises non-conformancies, conducts investigation. Follows up and documents closure of corrective and preventive actions.
▪ Executes temperature excursions assessments for product release.
▪ Executes procedures issuance/update in case of implementation new J&J quality standards or local regulation.
▪ Performs risk assessments in accordance with J&J policies in applicable processes for example deviations, change controls, regulatory standards management implementation and others. Ability to take risk-based decisions to identify priorities.
▪ Maintains quality records in accordance with records retention policies and quality records standard, in an accurate and timely manner.
▪ Coordinates change control/document control initiation and approval process.
▪ Collect and analyze information to support in the report preparation in the quality system management review (QSMR).
▪ Prepares for and facilitates internal audits and regulatory/corporate inspections.
▪ Follows up on annual distributors/suppliers qualification and monitoring management system. Conducts supplier/distributor selection, qualification if
needed.
▪ Periodically review the Regulatory Compliance System with RA team to ensure continouos compliance with all effective local regulations.
▪ Monitors trends, identifies issues, recommends and implements appropriate actions. Assists in the development, implementation and review of standard operating procedures.
▪ Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time.

Source:gotogulf