Senior Process Optimization Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro
Job Summary

We are seeking a highly experienced Senior Process Optimization Specialist to join our team at Thermo Fisher Scientific. As a key member of our Quality organization, you will be responsible for providing R&D Quality support to Affiliate Medical teams.

Key Responsibilities
  • Review, monitor, and approve controlled process documents for quality, compliance, and commitment gaps, in coordination with Sub Process Owners (SPOs) or Process Owners (POs)
  • Provide compliance support, including review, assessment, and approval of process deviations
  • Lead investigation and assist in Root Cause Analysis of Quality Issues (QI) and CAPA
  • Review and approve Quality Issues (QI)
  • Assist the CAPA owner in performing Root Cause Investigations, review, and approve CAPA actions
  • Monitor CAPA to completion
  • Support audits and inspections, including pre-inspection support, inspection readiness training, and mock interview sessions
  • Lead CAPA plan completion and CAPA monitoring to completion
  • Ensure R&D Quality Management System maintenance in the Affiliate Medical Teams
  • Support Affiliate Functional Learning Liaison in the maintenance of R&D QMS matrix, inform Functional Learning Liaison (FLL) of new hires and role changes in Affiliate Medical teams that affect R&D QMS activities
  • Ensure Affiliate Medical Teams have available nominated Affiliate PON representative and CAPA Functional Approver
  • Support Affiliate Medical Teams in the management of Medical GxP vendors
  • First point of contact for Affiliate Medical teams for R&D Quality-related questions
  • Assist Affiliate Medical teams with R&D Governance meetings and reports
  • Serve as overflow support for large-scale global audits and documentation requests, when needed
  • Monitor KQI/KPI's at the affiliate level related to these Quality activities
Additional Responsibilities
  • Proactively collaborate with initiative leads and management to prepare, organize, coordinate, document, and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements
  • Develop varied support materials, presentations, and/or tools to support department's remit and strategies
  • Lead small to medium-scale process improvement initiatives
  • Develop process improvement processes and solutions
  • Identify and collate information required to assess compliance with processes and to prioritize business process improvement needs
  • May review, assess, and update procedural documents for overall compliance with current processes
  • Perform special projects, assignments, and administrative tasks per business needs. Provide training and guidance to junior team members
Requirements
  • Degree in Life Sciences or Engineering
  • Minimum 2 years of experience in CAPA management and Quality Audit/Inspection support activities
  • Fluent in English - read, write, speak. Fluency in additional languages (such as Spanish, Portuguese, Chinese, Japanese, etc.)
  • Experience in TrackWise or other electronic Quality Management Systems (eQMS)
  • Experience in electronic Document Management System (eDMS)
Knowledge, Skills, and Abilities
  • Thorough understanding of procedural documents
  • Strong understanding of process improvement fundamentals
  • Solid investigative and analytical skills
  • Strong negotiation skills
  • Thorough understanding of clinical management technology and systems, and strong computer skills
  • Effective judgment, decision making, escalation, and risk management skills
  • Effective oral and written communication skills, including the ability to communicate in English, both orally and in writing
  • Strong interpersonal skills and problem-solving ability
  • Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
  • Strong attention to detail
  • Thorough understanding of regulatory guidelines and directives
  • Strong creative and critical thinking skills

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