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/. 

Commercial Quality Associate is part of the CQ team in Russia and CIS that are responsible to maintain Quality Management System in JnJ Innovative Medicine Russia and CIS to ensure that all locally marketed products and all local processes are following all applicable Johnson&Johnson and local regulation requirements.

Responsibilities:
The CQ specialist will be responsible for managing and executing the activities related to a few quality processes. Throughout the onboarding and the expertise that you are building the list of processes might change.

Documentation and Records Management
- Leading creation and maintenance of local quality documentation in respective e-system
- Leading Quality records management

Temperature excursion management
-Leading temperature excursion management process incl. assessment of temperature excursions, initiate investigations if needed, submit the final decision for the product release.

PSP program support
- Leading processes related to the quality aspects in frame of local PSP programs in Russia and CIS

Product Quality Reviews management
- Leading PQR management process incl. creation of PQR, creation and maintenance of PQR schedules.

Deviations management
- Manage deviations from initiation to closure incl. quality assessment and approval in respective e-system
- Monitoring of timely reporting, investigation and closure of deviations and follow up with responsible colleagues
- Periodical trend analysis.

CAPA management
- CAPA management incl. task actions from initiation to closure in respective e-system
- Monitoring of timely completion of CAPA and task actions and follow up with responsible colleagues
- Periodical trend analysis

Local release
- Execution of the process on Input of drugs in civil circulation in accordance with requirements of Federal law 61-ФЗ "Drugs Importation and circulation" in Russian Federation;
- Signing of the Confirmation of Conformity of the medicinal product with the requirements established during its state registration as a person authorized by the manufacturer to input the drugs in civil circulation in Russian Federation.

Internal audits
- Participation in internal audits
- Monitoring of CAPA initiated to address internal audits’ observations and follow up with responsible colleagues to assure their timely completion and closure

Support in Quality System Management Review preparation
-Preparation the information based on the area’s of responsibility

Support during Escalations and Field actions management

Involvement in any other activities per the manager’s request

Job Requirements:

• Team player and good communicator
• Accurate
• Responsible
• Diligence
• Positive mindset