Regulatory Affairs & Quality Assurance Officer AASO (M/V/X)

at  Ajinomoto BioPharma Services

FUNCTIE

You will follow up the quality assurance and regulatory affairs activities for our AASO activities.

This includes:

• Providing regulatory affairs and technical services activities
• You provide quality and regulatory support to customers
• You collect information and documentation from the concerned manufacturers
• You organise the received information in a database
• You implement efficient systems to handle routine matters and questions
• You contribute to the organisation of customers audits.
• Providing quality assurance activities regarding Distribution

• You evaluate and maintain compliance with Pharmaceutical regulations (GMP), ISO 9001 quality standard and quality policies of AOC/AASO by:

  o Developing and maintaining procedures
  o Performing internal & external audits
  o Following-up CAPA’s
  o Establishing and updating quality agreements with customers, suppliers, distributors and subcontractors

  o Managing and following-up the communication with suppliers, customers and partners with regard to quality complaints.

• Controlling the allocation of material codes to customers.

• Providing quality assurance activities regarding Import and Release of Pharmaceutical products
• You develop and maintain the quality system and documentation relating to the import and release
• You manage APR’s, follow-up deviations and CAPA plan
• You collect the batch release data and prepare the release documentation
• You manage temperature monitoring and data collection
• You communicate with subcontractors with regard to GMP and quality issues
• You coordinate quality actions and participate in audits performed by authorities and customers
• You report to the Regulatory Affairs & Quality Assurance Manager AASO.

Please refer the Job description for details