Quality Assurance and Regulatory Affairs Specialist (12-months fixed term contract) (manual)

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

As a Quality Assurance and Regulatory Affairs Specialist, you will ensure compliance with quality and regulatory requirements by managing complaints, field actions, CAPAs, product release activities, and training programs. You will also maintain product registrations and regulatory authorizations, coordinate submissions, and support product launches and commercialization activities throughout the product lifecycle.

Note: The selected candidate will be employed by an external company.

Complaint Management:

Field Action Management:

Training:

CAPA Management:

Release of Products:

Selling Authorization:

Regulatory document and submission:

• The function requires a bachelor's degree in Pharmacy, Chemistry or Chemical Engineering degree is preferrable.
• For a person with the specified education at least 2 years of professional experience in Quality Assurance and/or Regulatory Affairs in a Pharmaceutical/ Medical device or relevant industry is required.
• Experience as delegated QP (Qualified Person) is preferrable.
• Knowledge of GMP; GDP; ISO9001 and ISO 13485 is preferrable.
• Ability of understanding country specific regulations and general quality requirements.
• Very good spoken and written English.
• Strong communication and problem solving skills and follow-up actions.
• Ability to work cross-functionally and independently.
• Computer skills (Word, Excel, Power Point, Outlook, corporate software).
• Good organizational and time management skills.