KSA Commercial Quality Specialist

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Job Description:

J&J MedTech is recruiting for a KSA Commercial Quality Specialist reporting to the Manager Commercial Quality and to be based in Riyadh Saudi Arabia.

Overview of the role

Quality System Specialist performs quality support HA communications and medicovigilance (product complaints and Field safety corrective actions). Performs audits for 3PL suppliers and distributors. Supports supply chain and logistic activities.

Develop and work with corrective action and preventive action (CAPA). Provides support for special quality projects. Ensures and maintains a state of inspection readiness. Establishes and maintains quality assurance programs procedures and controls ensuring that performance parameters of the quality system elements are continually measured to drive improvement initiatives.

Role Description:

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.

Knowledge Skills Competencies and Experience:

University/Bachelors Degree or Equivalent in Life Science/Engineering/Quality management.

Fluent knowledge of English and Arabic

Masters and/or Certifications in Quality Assurance Project Management and innovation are a plus.

Good knowledge of SFDA regulation;

ISO 9001/13485 certificate (internal auditor and/or supplier auditor) IRCA certificate will be an advantage.

SAP/warehouse management system

Advanced analytical skills and ability to translate data and customer learning into actionable recommendations.

Ability to set network with different stakeholders (3PL Regulatory Affairs Commercial & Sales Supply Chain HCC and others);

Advanced communication and presentation skills as classroom and virtual trainings to big and small audiences;

Process methodology orientation & practice;

Microsoft Office (PowerPoint Excel Word Outlook Planner TEAMS);

Years of experience:

At least 3 years of experience in healthcare (medical/pharm/hospital) industry logistics supply chain quality assurance and Middle East/Africa Health Authorities Regulations. Process oriented individual.

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Preferred Skills: