Kıdemli Ticari Kalite Uzmanı / Senior Commercial Quality Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Istanbul, Turkey

Job Description:

Johnson & Johnson Janssen is recruiting for Senior Commercial Quality Specialist to be located in Istanbul, Türkiye.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Purpose: Janssen Turkiye Quality System and Quality Policy of Johnson & Johnson Standards and implemented in accordance with Ministry of Health requirements and ensure continuous improvement.

The position is accountable for the execution of the Quality Management Systems in TURGAN (Türkiye,Ukraine,Georgia,Azerbaijan) and Compliance at Janssen Distribution Center (3PL) within the corresponding geographical area of Türkiye, that receive, pick, pack, store, inspect, repack/relabel and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.

The position supports Deliver and Supply country operational team on Distribution of products.

You will be responsible for:

QUALITY ASSURANCE:

• Janssen Turkey Quality System and Quality Policy of Johnson & Johnson Standards implementation in line and ensure continuous improvement.
• Examines the regulations / procedures of the Ministry of Health in line with company strategies, ensures compliance with them and undertakes the responsibility for them.
• Manages the product and service supplier processes within the scope of Quality requirements. Ensures supplier qualification, organizes, and conducts inspections and participates.
• Ensures that the procedures related to the quality system are prepared, updated, and trained in accordance with Janssen International Quality System Guidelines, “Good Manufacturing Practice” and “Good Distribution Practice”,
• Checks the format conformity of newly published or updated procedures.
• Ensures systematic management of parameters measuring process efficiency within the scope of the Quality System,
• Provides support to the LOC CQ Head and RM in systematically managing the parameters measuring process efficiency within the scope of the Quality System and sharing them periodically with the management team.
• In accordance with the local regulation, provides the reporting process of “Consumption stock notification of products within the scope of Narcotics” through the system of Ministry of Health, EBS and supports the process follow-up.
• Obtains and reviews the annual product evaluation reports in accordance with the Quality System,
• Ensures the management and tracking of Quality Issues, CAPA and Deviation management and CoC processes,
• Support to the LOC CQ Head and RM in recall and escalation situations
• Ensures that the annual Internal and External Audit Plans are prepared, and these audits are carried out.
• Ensures system entry and follow-up of customer complaints and coordination with relevant units.
• Tracks the packaging material code of the products.
• GxP contributes to the organization of quality system training of relevant units.
• Ensures that the training of GxP relevant units for local GxP related procedures is managed through training systems.
• Performs batch/product release, batch record review, temperature excursion and activities as delegated by Responsible Manager

Compliance with Company Procedures & Ethical Principles:

• Ensures compliance with relevant agreements, legal requirements, ethical standards, Corporate Business and Security Procedures and HCBI.
• Contributes to the LOC CQ Head and RM in terms of being ready for audit.
• Fulfills confidentiality principles.

Professional & Personal Development:

• Participates in training programs and applies newly acquired knowledge and skills.
• Gains in-depth knowledge of “Good Manufacturing Practice” legislation and other relevant Official Regulations and Laws.
• Contributes to the LOC CQ Head and RM to prepare and carry out trainings for Company employees and 3rd party employees.
• Work towards a solution via artificial intelligence, use new platforms . Understanding of the definition of the term; the implications for people, processes, and technology;
• Contributes to support the digital transformation efforts of the CQ and business and essential elements of data science, science applications and innovations and supports for creation a common data science vocabulary

System Development:

• Provides effective feedback to the LOC CQ Head and RM on potential system development issues.
• Works towards continuous improvement and development of the Quality Management System.

Interaction with Business Partners:

• Collaborates effectively with business partners (Logistic department, competitors, Medical Affairs, Sales & Marketing & Operations and not limited to)

Qualifications / Requirements:

• Having a Science related bachelor degree is a must (Ex: Pharmacy, Chemistry, Chemical Engineering)
• Having minimum 2 years of experience in quality systems is a must,
• Fluent English is a must,
• Mastering MS Office applications
• Analytical Thinking skills
• Result oriented
• Job tracking and ability to give effective feedback
• Digital Skill and capabilities and agility and understanding in artificial intelligent and technology solutions are preferable.
• Russian or Ukrainian language knowledge is an asset

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