CMC Quality Solutions Specialist

Pauwels Consulting; Eigenbrakel; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a quality assurance professional to support QMS activities across late-stage development and commercial products. You will manage change controls, risk management, and SOP development, ensuring audit readiness and strong document control.

You will review CMC sections for regulatory submissions, help prepare product launches from a quality perspective, and work autonomously in a multi-cultural environment while communicating clearly with stakeholders.

Qualifications

• Bachelor's Degree.
• 3+ years of experience in the pharmaceutical or biologics industry in a quality management position.
• Experience in quality assurance including change control, risk management, and SOP development.
• Ability to work autonomously, analyze data for decision-making, and adapt to multi-cultural environments.
• Proactive and solution-oriented with strong interpersonal and communication skills.
• Fluent in English.

Responsabilités

• Support quality assurance activities throughout the product lifecycle.
• Manage change control committees and follow up on associated change controls.
• Maintain and manage the lifecycle of quality assurance product flows and related control documentation.
• Ensure audit and inspection readiness through proactive preparation and participation.
• Review and approve CMC sections for regulatory submissions, renewals, and variations.
• Support the preparation and execution of product launches from a quality perspective.
• Identify risks and propose corrective actions while monitoring product metrics and stability plans.

Connaissances

Quality management

Data analysis

Interpersonal communication

Autonomous working

English proficiency

Formation

Bachelor's degree

Description du poste

Our client, a global pharmaceutical organization, is seeking a professional to support quality assurance activities throughout the product lifecycle. This role involves managing quality processes for late-stage development and commercial products, including submissions, launches, and product improvements.

• Support product change control committees and follow up on associated change controls.
• Maintain and manage the lifecycle of quality assurance product flows and related control documentation.
• Ensure audit and inspection readiness through proactive preparation and participation.
• Review and approve CMC sections for regulatory submissions, renewals, and variations.
• Support the preparation and execution of product launches from a quality perspective.
• Identify risks and propose corrective actions while monitoring product metrics and stability plans.

• You have a Bachelor's Degree.
• You bring 3+ years of experience in the pharmaceutical or biologics industry in a quality management position.
• You possess experience in quality assurance including change control, risk management, and SOP development.
• You have the ability to work autonomously, analyze data for decision-making, and adapt to multi-cultural environments.
• You are proactive and solution-oriented with strong interpersonal and communication skills.
• You are fluent in English.

Nice to Haves

• Operational experience in GMP within quality, manufacturing, or Quality Control.
• Experience with GMP audits, inspections, Data Integrity assessments, or CMC Regulatory requirements.
• Proven skills in project management.