Validation Specialist

3 semanas atrás

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.
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