Commercial Quality Analyst

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

There is a pre-identified candidate for consideration that has been identified. However all applications will be considered

This is a fully on site position to be executed in Embu das Artes

Overall purpose of job:

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.

DUTIES AND RESPONSABILITIES:

• 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 among others).
• 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.

EXPERIENCE AND EDUCATION:

• University/Bachelors degree in pharmacy chemical engineering life-science or health-related discipline.
• Generally Requires 2-4 Years Work Experience in a Quality Role within Medical Device Pharmaceutical Consumer Good Food or other GMP controlled environment.
• Intermediate English required. Spanish desired.
• Experience to receive audits with regulatory agencies (CRF-SP/CRQ-SP related ANVISA VISA INMETRO).
• Previous experience in a Quality / Regulatory Role is essential.

REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES AND AFFILIATIONS:

• Comprehensive knowledge of Quality Systems and Regulations.
• 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.
• Analytical skills and practical mastery of quality tools (5 whys Ishikawa 5S PDCA).
• Good problem-solving skills.
• It is desired that the job holder is a qualified Auditor.

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Preferred Skills: