RA & QA Specialist

Key responsibilities

1) General QA & RA Responsibilities

• You play a central role in how our RA & QA team operates; You organise and coordinate all regulatory activities, ensuring the team works smoothly and consistently.

• You support and coach RA & QA Officers, helping them grow and ensuring high‑quality output.
• You keep our regulatory SOPs aligned with Ajinomoto Co., Inc. global standards, and help shape regulatory strategies for new and ongoing projects,
• You work closely with Ajinomoto affiliates and key customers, representing Ajinomoto in regulatory discussions, building trust and long‑term partnerships.

2) Regulatory Affairs & Technical Support

• You are the reliable link between our manufacturing sites, our customers, and internal teams, you manage the information flow within the RA department so that everything is accurate, traceable, and delivered on time.

• You provide clear, confident regulatory support to customers, you speak their language and guide them through complex topics, and prepare and validate regulatory and quality statements that customers rely on.
• You coordinate change control activities from A to Z: communication, documentation, approvals, and follow‑up, and you ensure we are ready for customer audits.

3) Quality Assurance Activities – Distribution

• You help safeguard the quality and reliability of our distribution activities, and approve material code allocations for customers, keeping our processes compliant and consistent.
• You manage customer complaints with professionalism and a solution‑oriented mindset.
• You establish and maintain quality agreements with customers, suppliers, distributors, and subcontractors; ensuring expectations are clear and aligned.

4) Contribution to AASO Strategy

• You perform regulatory assessments for projects initiated by AASO or Ajinomoto globally, ensuring compliance from the start, and anticipate customer needs and regulatory expectations, contributing to a proactive and forward‑looking strategy.
• You participate in internal, global, and customer project meetings and ensure that all regulatory aspects are followed up thoroughly.

Profile

• You have a master’s degree in a scientific field (Industrial Pharmacist, Chemist, Bio‑Engineer, Industrial Engineer, …) with 5–10 years of experience in Regulatory Affairs and exposure to Quality Assurance within the pharmaceutical or related industries.

• You are methodical, accurate and structured in approach, you have a strong ability to assess situations realistically, identify risks and propose balanced solutions.
• You demonstrate a clear helicopter view, and are able to oversee processes across the entire organisation and its external partners, proven project management capabilities.
• You’re an effective communicator in English (spoken and written); additional languages are an asset.
• You’re resilient under pressure, able to set the right priorities and meet deadlines.
• You have strong IT skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP and SharePoint is a plus.