Summary
Entry level to developing individual contributor, who works under close supervision. Coordinates tasks related to fulfilling the quality and regulatory requirements and established standards and customer needs for the organization's products, processes, and services. Implements strategy and vision of continuous improvement and feedback through assessments and reporting. Develops close partnership with all marketing companies functions and external business partner to identify risks and improvement opportunities and enhance the customer experience.
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
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
São Paulo, BrazilJob Description:
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
COMMERCIAL QUALITY ANALYST - Surgical Vision - Fixed Period 9 months
Johnson & Johnson Vision is recruiting for a COMMERCIAL QUALITY ANALYST - Surgical Vision, located in Embu das Artes, São Paulo, Brazil - Fixed Period 9 months.
Performs and maintains quality assurance programs, supplier systems, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Provides support for quality projects. Ensures and maintains a state of inspection readiness to Johnson & Johnson Vision business.
Key Responsibilities:
Complies with company policies, procedures, and quality standards, as well as safety and environmental regulations.
Develops solutions basic scope and intermediate complexity.
Assists in writing standard operating procedures. Performs and provides support for the product review and release functions.
Identifies significant trends. Generates statistical summaries. Participates in quality system improvement initiatives.
Provides support to Supply Chain in Quality related subjects.
Assists in the documentation of corrective action plans and monitors implementation and follows up on closure of corrective and preventive actions.
Coordinates the impact assessment of the regulatory requirements applicable to Distribution Center, when defined by the Commercial Quality Leader.
Support internal and external quality audits (Corporate J&J, VISA, CRF/CRQ related, INMETRO, etc.)
Supports internal/external and suppliers audit activities, responses, and compliance with due dates.
Ensures the updating and maintenance of the regulatory documentation related to the regulatory agency related to the website under his responsibility.
Monitors trends, identifies issues, recommends and implements appropriate actions.
Assists in the development, implementation and review of standard operating procedures for interactions with 3PL (Distribution Center) as J&J oversight.
Acts as Technical responsible for Distribution Center.
Ensures the updating and maintenance of the regulatory documentation related to the regulatory agency related to the site under his responsibility.
Assists in the development, implementation and review of standard operating procedures for interactions with 3PL (Distribution Center).
This role reports directly to the Commercial Quality Operations Sr. Supervisor.
Qualifications
- University degree in pharmacy, chemical engineering, life-science or health-related discipline.
- Acts as Technical responsible for Distribution Center.
- 2-4 years’ experience in quality role: pharmaceutical, medical devices or related experience.
- Intermediate English required.
- Management of the documentation of the quality system according to ISO 13485 and GMP standards. Comprehensive knowledge in regulatory affairs, regulations, GMP legislation and general product.
- Analytical profile with strong verbal and written communication skills; high personal accountability, proactive and problem-solving skills.
- Accountability to work with a medium level of supervision; strong team player with initiative who collaborates well with internal / external partners.
- Practical mastery of quality tools (5 whys, Ishikawa, 5S, PDCA).
- Lead auditor certification – ISO 13485 will be a nice to have
- Experience to receive audits with regulatory agencies (CRF-SP/CRQ-SP related, ANVISA, VISA, INMETRO).
- Previous experience in a Quality / Regulatory Role is essential.
