Validation Specialist

Há 6 horas

Campinas, Brasil Optel Group Tempo inteiro

Validation Specialist

A certified B Corp, OPTEL is one of the world's leading providers of traceability systems. Its mission is to use its innovative technologies to create a better world through responsible capitalism. The company's renowned solutions guarantee the quality of healthcare products and help combat the counterfeiting of drugs and medical devices around the world. OPTEL also adapts its technologies to different sectors—from healthcare to smart manufacturing and beyond—all of which can benefit from global traceability. OPTEL's expertise will enable various industries to measure, inspect, control, and track a wide variety of items to improve product quality and ensure more responsible use of resources.

Summary

The Validation Specialist is responsible for creating and updating validation documents (internal protocols, Installation Qualification (IQ), Operational Qualification (OQ), Change Controls) to ensure that OPTEL systems comply with industry standards. This role requires strong expertise in documentation as well as the ability to collaborate effectively with internal teams and clients to ensure compliance, quality, and project reliability.

Please submit your resume in English.

Responsibilities

Validation Documentation and Management:

  • Develop and maintain standardized validation templates that comply with industry standards and regulatory requirements (GAMP, FDA 21 CFR Part 11, EU Annex 11).
  • Review and interpret system updates (new releases, patches) to assess their impact on validation documents.
  • Produce validation documents for clients based on functional and design specifications of projects.
  • Execute internal validation protocols as needed to ensure system functionality and compliance.

Risk Analysis and Quality Improvement:

  • Actively participate in risk assessments to identify validation-related issues and define necessary mitigation plans.
  • Identify root causes of validation nonconformities and deploy corrective actions with a focus on continuous quality improvement.

Collaboration and Expertise:

  • Coordinate with various internal departments to deliver validation documentation at key project milestones.
  • Advise internal teams and clients on best practices and validation strategies.
  • Work in collaboration with the Quality Assurance (QA) team to ensure compliance with internal and regulatory standards, including participation in internal and external audits.
  • Perform any other related tasks associated with validation processes.
Required Skills
  • College diploma in a relevant field or equivalent experience.
  • Minimum of 2 years’ experience in system validation/testing or technical writing.
  • Proficiency in Portuguese and English required.
  • Advanced knowledge of Microsoft Office Suite (Word, Excel). Rigor, analytical mindset, and attention to detail. Ability to collaborate effectively in a team and communicate with stakeholders at all levels. Strong curiosity and willingness to learn and adopt new technologies, especially artificial intelligence.

Advantages and benefits

  • Flexible work schedules;
  • Remote working mode;
  • Competitive compensation;
  • Healthcare plan;
  • Life Insurance;
  • Meal allowance (Ticket);
  • Wellhub.
#J-18808-Ljbffr

  • Validation Specialist

    Há 3 dias

    Campinas, Brasil Optel Tempo inteiro

    Validation Specialist A certified B Corp, OPTEL is one of the world's leading providers of traceability systems.Its mission is to use its innovative technologies to create a better world through responsible capitalism.The company's renowned solutions guarantee the quality of healthcare products and help combat the counterfeiting of drugs and medical devices...

  • Validation Specialist

    Há 13 horas

    Campinas, Brasil Optel Group Tempo inteiro

    Validation SpecialistA certified B Corp, OPTEL is one of the world's leading providers of traceability systems.Its mission is to use its innovative technologies to create a better world through responsible capitalism.The company's renowned solutions guarantee the quality of healthcare products and help combat the counterfeiting of drugs and medical devices...

  • Validation Specialist

    Há 4 dias

    Campinas, São Paulo, Brasil Optel Group Tempo inteiro R$60.000 - R$120.000 por ano

    Validation Specialist A certified B Corp, OPTEL is one of the world's leading providers of traceability systems. Its mission is to use its innovative technologies to create a better world through responsible capitalism. The company's renowned solutions guarantee the quality of healthcare products and help combat the counterfeiting of drugs and medical...

  • Validation Specialist

    Há 2 dias

    Campinas, São Paulo, Brasil Optel Group Tempo inteiro R$60.000 - R$120.000 por ano

    Validation Specialist A certified B Corp, OPTEL is one of the world's leading providers of traceability systems. Its mission is to use its innovative technologies to create a better world through responsible capitalism. The company's renowned solutions guarantee the quality of healthcare products and help combat the counterfeiting of drugs and medical...

  • Validation Specialist

    Há 8 horas

    Campinas, Brasil Optel Group Tempo inteiro

    Validation Specialist A certified B Corp, OPTEL is one of the world's leading providers of traceability systems. Its mission is to use its innovative technologies to create a better world through responsible capitalism. The company's renowned solutions guarantee the quality of healthcare products and help combat the counterfeiting of drugs and medical...

  • Salesforce Data Migration Specialist

    3 semanas atrás

    Campinas, Brasil buscojobs Brasil Tempo inteiro

    Overview About Us : Kelley Austin takes a different approach to Salesforce Consulting by putting our employees first. That’s not hyperbole, either. Our team takes a proactive approach to employee satisfaction by having every single person fill out a “happiness list,” which comprises the top ten things each employee finds happiness in outside of...

  • Database Migration Specialist

    Há 4 dias

    Campinas, Brasil AgileEngine Tempo inteiro

    OverviewDatabase Migration Specialist (Senior/Lead) – ID41867 AgileEngine is an Inc. 5000 company that creates award-winning software for Fortune 500 brands and startups across 17+ industries. We rank among the leaders in application development and AI/ML, and our people-first culture has earned multiple Best Place to Work awards. If you're looking...

  • Database Migration Specialist

    Há 2 dias

    Campinas, Brasil AgileEngine Tempo inteiro

    Overview Database Migration Specialist (Senior/Lead) – ID41867 AgileEngine is an Inc. 5000 company that creates award-winning software for Fortune 500 brands and startups across 17+ industries. We rank among the leaders in application development and AI/ML, and our people-first culture has earned multiple Best Place to Work awards. If you're looking for a...

  • Tech Projects Specialist

    Há 4 dias

    Campinas, São Paulo, Brasil AB InBev | Growth Group Tempo inteiro R$60.000 - R$120.000 por ano

    About usAB InBev is the leading global brewer and one of the world's top 5 consumer product companies. With over 500 beer brands, we're number one or two in many of the world's top beer markets, including North America, Latin America, Europe, Asia, and Africa.About AB InBev Growth GroupCreated in 2022, the Growth Group unifies our business-to-business (B2B),...

  • Tech Projects Specialist

    Há 4 dias

    Greater Campinas, Brasil AB InBev Tempo inteiro US$70.000 - US$120.000 por ano

    About usAB InBev is the leading global brewer and one of the world's top 5 consumer product companies. With over 500 beer brands, we're number one or two in many of the world's top beer markets, including North America, Latin America, Europe, Asia, and Africa.About AB InBev Growth GroupCreated in 2022, the Growth Group unifies our business-to-business (B2B),...