Senior Validation Professional

1 semana atrás

Região Geográfica Intermediária de São Paulo, Brasil beBeePharmaceutical Tempo inteiro €75.000 - €97.000
Regulatory Validation Specialist

We are seeking an exceptional individual to join our team as a Regulatory Validation Specialist in a cGMP regulatory environment.

Job Overview:

The successful candidate will play a key role in supporting various aspects of validation, including sterilization, cleaning, isolator qualification, controlled temperature units, and filter validation.

  • Sterilisation – Autoclaves, SIP of vessels
  • Cleaning – Parts Washer and CIP of vessels
  • Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systems
  • Controlled Temperature Units (CTU) – Temperature/Humidity Mapping
  • Filter Validation
Key Responsibilities:
  • Developing, reviewing, and approving qualification/validation documentation and cycle development studies.
  • Authorizing/Reviewing/Applying/Executing execution/development of change controls.
  • Resolving technical issues encountered during study execution.
  • Engaging with Production, Maintenance and Quality representatives in the assigned area of operations.
  • Providing technical input into quality notification by authoring/reviewing/approving investigations.
  • Performing root cause analysis of system failures, substandard performance, using standard tools and methods.
  • Supporting continuous improvement through Lean Six Sigma methodologies.
  • Serving as validation representative for cross-functional projects.
  • Ensuring compliance of Global Policies, Procedures and Guidelines, regulatory requirements, and executing current Good manufacturing Practices (cGMP).
  • Being accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections.

The successful candidate will work independently and in a cross-functional team to accomplish validation project objectives.

Requirements:
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Knowledge of CTU equipment qualification.
  • Knowledge of thermal mapping equipment.
  • Thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Demonstrable experience of leading technical related projects.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Excellent communication, presentation, and interpersonal skills.

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