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Quality

Janssen Turkey - Senior Commercial Quality Specialist

  • ชื่อเรื่อง Janssen Turkey - Senior Commercial Quality Specialist
  • การทำงาน Quality
  • ฟังก์ชั่นย่อย Quality Assurance
  • ตำแหน่งที่ตั้ง Istanbul, Turkey
  • โพสต์
  • ID การร้องขอ 2306148043W
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การบรรยาย

Janssen is recruiting for a Senior Commercial Quality Specialist to be located in Istanbul (Turkey) and reporting to the Senior Quality Assurance & Responsible Manager.

The Snr. Commercial Quality Specialist is responsible for the quality of, and meeting the applicable requirements for, the products that the LOC markets, or the products that it produces for other companies (including all named-patient materials, product samples and/or clinical supplies).

He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. In this role he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Quality Manual and J&J Quality Management System and batch release to the market.

Main activities/tasks:

Quality Systems

·       Implement the Quality System via transposition of the requirements of the Commercial Quality Manual (CQM) and J&J Quality Management System

·       Prepare, update and approve LOC procedures in accordance with local GMP/GDP, CQM and J&J requirements

·       Execute batch release to the market.Delegation of Responsbile Manager role, when needed

·       Execute minimum requirements regarding lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity

·       Ensure the provision of appropriate training for all job functions with GMP/GDP responsibilities

·       Ensure appropriate internal and external change control systems are in place and are followed

·       Manage the preparation, execution and follow up for external inspections, and report these and any other relevant field action activity into the CURVE

·       Monitor quality system performance versus local GMP/GDP, CQM and J&J requirements via use of pertinent business and compliance metrics and goals

·       Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews

·       Notify and engage LOC Quality Head and Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures outlined in CQM

Quality Processes

·       Ensure an effective procedure and adequate system to handle product and PQC complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner (including outside business hours, plus COMMERCIAL QUALITY HEAD backup in every case of absence)

·       Ensure suppliers of any critical materials (all product related suppliers & services) are qualified and periodically audited against company & local GMP standards

·       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

·       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

·       Ensures that the annual Internal and External Audit Plans are prepared, and these audits are carried out

·       Conduct regular (self-)inspections of GMP/GDP practices that are applicable on the supply chain within the responsibilities of the Local Operating Company

                     ·   Support to the LOC CQ Head and RM in recall and escalation situations

·       Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management

·       Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes

·   Implement departmental strategies and services as the business expert on quality systems, distribution, and quality management in collaboration with Enterprise Commercial Quality, implement common distribution standards and Quality Management Systems (where appropriate)

·       This role will optimize quality systems and processes and ensure alignment with the worldwide

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

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 (Logistics Department, Finance, Medical, Regulatory Affairs, PV, Sales & Marketing, Sales Operations, Warehouse Operations, Deliver, External Manufacturers, Logistics, etc.)

Digital Skill and Capabilities

·       Ability and agility to deliver high-quality, high value technology solutions understanding of use of automated techniques and tools

·       Provide technology solution requirements in a manner that can be easily consumed by the business, design, build, test, training, and operations

·       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

คุณสมบัติ

The Senior Commercial Quality Specialist should meet the following knowledge, experience and skills:

·       Primary degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline

·       At least  3/5 (ideally 5) years experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management, Regulatory Affairs and some Sales & Marketing , Medical Devices , Digital Pharm Applications, Digitalize product experiences. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential

·       Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes and digital asset / application pharm integration, digitize products, services, and other elements of the digitalization in pharma

·       Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP

·       Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners

·       Knowledge and full understanding of the J&J Quality Policy (POL 001), and the procedures and processes outlined in this Manual

·       Full competency in local languages and a working knowledge of English

·       Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc.

Proven success in:

·       Quality Management experience

·       Compliance experience, QMS experience

·       Understanding the linkages in quality and regulatory compliance in delivery to customer and health authority

·       Change management and project management experience

·       Strong presentation skills

·       Issue remediation experience

·       Collaborative approach

·       Managing complexity

·       Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed, etc

·       Background in Commercial Quality System Tools, digitilized products and technology & digitalized solutions

Special requirements:

·       Auditor (self & supplier) certification is preferable

·       Expected to demonstrate the Leadership Imperatives

·       Fluent English and local language

·       ISO 9001/13485 Experience is preferable

·       Digital Skill and capabilities and agility and understanding in artificial intelligence and technology solutions are preferable

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Turkey are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

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