Job Information
J&J Family of Companies Commercial Quality Specialist in Central Serbia, Serbia
Commercial Quality Specialist - 2406188795W
Description
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/
Within J&J MedTech, we are recruiting a Commercial Quality Specialist to be based in Belgrade (Serbia).
Overall purpose of job
Responsible for Medical Device Vigilance in Serbia, lead the local QA organization and support the regional organization, to ensure implementation, maintenance and upgrading of the local Quality Management System and Standard Operating Procedures to drive compliance of all GXP related processes and support CEE South region (CEESAT region as required)
Essential duties and responsibilities:
Lead the local QA organization and support regional organization to ensure implementation, maintenance, and upgrading of the local Quality System and SOPs to drive compliance of all GXP-related processes
Responsible person for Medical Device vigilance ensuring local organization compliance
Ensure efficient information flow and effective communication of all relevant quality and regulatory (when required) matters within the Serbian affiliate
Having an overview of local and international regulatory and legislative requirements and communicating them to local/regional and Global Quality Assurance when required
Ensure an adequate process is in place to report and monitor the predefined KPI's, in alignment with Global QA and local affiliate. Assure that gaps are addressed appropriately and escalate critical trends to Management Team and Global QA
Provide quality oversight and direction to local third parties and ensure that they are qualified to perform their activities
Ensure readiness of local affiliate for all GxP regulatory inspections. Ensure management of external inspections, complaints, deviations, recalls, counterfeits and product tampering
Ensure that local and/or regional audits and self-inspections are performed within the organization and at 3rd parties, as appropriate. Ensure that any deficiencies identified through audits or other means are addressed
Ensure that within the local affiliate a GxP training program is established and training timely performed, documented and its effectiveness checked
Other features of the job:
- Travel across CEE South and CEESAT region when required
Job location:
- Serbia. Travel to other CEE South countries under the same QMS and CEESAT countries (if required)
Qualifications
- Bachelor's or Master's degree in medicine, dentistry, pharmacy, technology, electrical engineering, mechanical engineering, or chemistry
Essential knowledge and skills:
Previous experience in Quality is essential. Regulatory experience is an advantage
Experience as a responsible person for Medical Devices Vigilance is preferred
Preferred experience includes 3 years in a Quality role within a Medical Device or GMP-controlled environment
Knowledge of Serbian legislation regarding Medical Devices Vigilance is required. Knowledge of other relevant regulations is an advantage
Experience with the quality standard ISO 9001 is necessary
Certified lead auditor with experience in ISO 9001, supplier audits, and internal audits
Experience in Nonconformance, CAPA, and Change Management
Strong collaboration skills and the ability to build partnerships both internally and externally
Excellent written and oral English communication skills and local language
Johnson & Johnson is an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location Europe/Middle East/Africa-Serbia-Central Serbia-Belgrade
Organization Johnson & Johnson S.E., Inc. Slovenia (7395)
Job Function Customer/Commercial Quality
Req ID: 2406188795W
J&J Family of Companies
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