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Commercial Quality Assurance Expert

hace 2 semanas

Santiago, Metropolitana, Chile Takeda A tiempo completo

About the Role

The Senior Quality Improvement Analyst position at Takeda is focused on ensuring the quality of processes and product outputs. The successful candidate will be responsible for defining and specifying activities, processes, and standards to meet quality requirements.

This role involves auditing, monitoring, and determining the quality of processes or outputs. The Quality Process Lead will support Takeda's mission by ensuring compliance with internal and regulatory standards, thereby maintaining product integrity and safety.

Key Responsibilities

  1. Define and specify activities, processes, and standards to fulfill quality requirements
  2. Audit, monitor, and determine the quality of processes or outputs
  3. Conduct product integrity testing, including coloring, fitting, pattern, and wet processing
  4. Report on process deviations and defects
  5. Manage projects and processes independently with limited supervision
  6. Coach and review the work of lower-level professionals
  7. Address moderate scope problems and apply judgment within defined procedures and policies

Skills and Qualifications

  • Applies basic quality assurance principles in routine situations, requiring guidance to ensure compliance and safety
  • Understands and applies basic safety assurance concepts under close supervision to maintain workplace and product safety
  • Conducts audits with ongoing supervision, applying basic auditing principles in straightforward situations
  • Identifies flaws and learns to apply corrective and preventive actions with guidance
  • Applies investigation techniques in simple cases with supervision, ensuring thorough examination and compliance
  • Follows established change control procedures with supervision, understanding their importance in quality management
  • Utilizes Quality Management Systems with guidance, ensuring adherence to regulatory standards
  • Applies basic quality control principles with some coaching, ensuring product integrity
  • Focuses on details, identifying key elements in tasks with supervision to maintain high quality standards
  • Develops writing skills, understanding basic grammar and punctuation to produce clear documentation
  • Gains practical experience in biotechnology, performing tasks with guidance to understand biological processes
  • Enhances interpersonal communication skills, requiring ongoing supervision to effectively communicate within the team

What You'll Be Doing

You will receive assignments with objectives and goals, providing guidance to employees based on established policies. Your work will be reviewed by management to assess goal achievement and adherence to policies, with opportunities to recommend policy changes within your unit or sub-unit.

Work Environment

This role involves frequent use of industry practices and general knowledge, ensuring project completion on schedule. You will primarily liaise internally with subordinates and supervisors, with minimal external contacts and guidance.