Operational Excellence Associate, Breda, Noord-Brabant

The Company
Our client is focused on advancing biotech innovation with drugs  for small cell lung cancer. They’re also driving AI in clinical trials to speed up medicine development.

The Role
This role focuses on ensuring manufacturing processes comply with regulatory standards and internal quality requirements. The role involves leading investigations into deviations, conducting risk assessments, managing documentation, and supporting investigations related to materials and complaints

Responsibilities

• Lead and support deviation investigations to ensure compliance with regulatory and internal standards.

• Conduct risk assessments to identify potential issues and implement corrective actions.

• Manage and maintain documentation related to manufacturing processes and compliance.

• Assist in investigating material-related issues to ensure smooth manufacturing operations.

• Support complaint investigations by providing assessments related to manufacturing process controls.

• Drive continuous improvement initiatives to enhance manufacturing processes and compliance.

• Ensure safety and quality standards are executed flawlessly to deliver high-quality products.

• Provide training and support to manufacturing staff to ensure compliance with processes and procedures.

• Bachelor's degree in Engineering, Manufacturing, Quality Assurance, or a related field.

• Minimum 3 years in manufacturing with a focus on compliance and operational excellence.

• Strong analytical, problem-solving, communication, and interpersonal skills.
• Lean Six Sigma Yellow Belt or higher (preferred).
• Attention to detail, leadership abilities, collaboration skills, and adaptability to changing processes and regulations.

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