Quality System Sr Analyst

1 semana atrás

São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough.

Johnson & Johnson Vision is recruiting for a Senior Quality Analyst to work in the Americas region.


The Commercial Quality System Senior Analyst will support overall quality activities associated with the Diamond Project, will report to the Commercial Quality Systems & Performance Sr.

Manager and will be responsible for development and implementation of quality systems based on business, regulatory and customer requirements. Also provides training and consultation to various parts of the business and resolves procedural breakdowns.

COMMERCIAL QUALITY SYSTEM SENIOR ANALYST VISION - PG2- São Paulo:

Key Duties and Responsibilities:

  • Be the QA representative on the Diamond Project supporting the Commercial Quality Cluster Leaders and acting as a liaison to address the project and business needs to guarantee compliance in both JJ Standards and Regulatory requirements.
  • Ability to read and interpret global documents and regulatory requirements and translate/reflect it at SOPs and work instructions as appropriate.
  • Utilizes multifaceted industry and process excellence standards on an expert level in daily quality activities, including but not limited to good manufacturing practices (GMP) and international organization for standardization (ISO).
  • Oversees audits of all quality system categories to assess compliance to process excellence standards. (JJRC, HA inspections among others).
  • Build, support, assess and review complex quality records as required (not limited to)

Eg :
non conformances, investigations, CAPAs, change requests and changes to documentation and processes.

  • Handles complex process issues.
  • Support and drive the effective implementation and maintenance of Vision QMS requirements, ensuring awareness and continuous education within the applicable areas.
  • Identify, analyze and address gaps, recommend initiatives for continuous improvement and compliance enforcement.
  • Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline.
  • Support and drive the quality tools / IT systems usage.
  • Support other activities/projects as required.

Qualifications:

Qualifications:

Education:

  • University/bachelor's degree in Engineering, Pharmacy, Technical discipline or related areas.
  • Generally, requires 46 Years Work Experience in a Quality Role within Medical Device, Pharmaceutical, Consumer Good, Food or other GMP controlled environment.
  • Language: English, Portuguese and Spanish intermediary / advanced.

Experience and Skills:

Required:

  • Ability to proactively identify improvement opportunities.
  • Project management
  • Good influencing and interpersonal skills with multiple levels of the organization.
  • Ability to manage multiple priorities and deliver excellent results.
  • Proactive team player, able to take charge and followthrough.
  • Strong teaming and collaboration skills.
  • Excellent written and verbal communications skills.
  • Cultural sensitivity as well as an ability to work in a matrix environment are required.
  • Achievementoriented with a high degree of flexibility and ability to adapt to a changing environment.
  • Ability to positively influence peers, key stakeholders and management.
  • Regulatory knowledge is essential.

Preferred:

  • Previous industry experience working with different processes that are part of the quality management system.
  • Previous project experience.
  • It is preferred that the job holder is a qualified Auditor.
  • Previous experience working within regional organizations.
  • Advanced Knowledge in excel / Power BI or other tools that enable automation in data analysis.

Other:

  • Travel availability (up to 20%) upon request.
  • Location: Sao Paulo / Brazil

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