Impact-Driven QA & Regulatory Affairs Specialist

Zvh; Fatih; On-site; TRY 200,000 - 380,000; Full time

Job summary

Baxter is seeking a Quality Assurance and Regulatory Affairs Specialist to ensure compliance across complaints, field actions, CAPAs, and product releases. You will maintain registrations and coordinate submissions, supporting launches and lifecycle management in Turkey.

The role requires a pharmacy/chemistry/engineering background with 2+ years in QA/RA, knowledge of GMP/GDP and ISO standards, and strong English communication. This is a pivotal position within Baxter’s regulatory team.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry or Chemical Engineering.
• At least 2 years of professional QA/RA experience in Pharmaceuticals or medical devices.
• Experience as delegated QP is preferable.
• Knowledge of GMP; GDP; ISO 9001 and ISO 13485 is preferable.
• Very good spoken and written English.

Responsibilities

• Complaint Management: be Local Complaint Coordinator (LCC) and notify authorities for reportable complaints.
• Field Action Management: act as FA Contact Person per Baxter procedures and regulations; train back-ups.
• Training: train employees and ensure training records; train distributors and service providers on Baxter requirements.
• CAPA Management: manage Non-Conformity Reports and CAPA.
• Release of Products: perform release for distribution per procedures and local requirements.
• Selling Authorization: perform selling authorization per procedures for Turkey.
• Regulatory document and submission: develop and execute regulatory plans for projects; maintain licenses.

Skills

Quality Assurance

Regulatory Affairs

Communication

Problem solving

Cross-functional teamwork

Training

Education

Bachelor's degree in Pharmacy, Chemistry or Chemical Engineering

Tools

MS Word

MS Excel

MS PowerPoint

MS Outlook

Corporate software

Job description

Baxter is seeking a Quality Assurance and Regulatory Affairs Specialist to ensure compliance across complaints, field actions, CAPAs, and product releases. You will maintain registrations and coordinate submissions, supporting launches and lifecycle management in Turkey.

The role requires a pharmacy/chemistry/engineering background with 2+ years in QA/RA, knowledge of GMP/GDP and ISO standards, and strong English communication. This is a pivotal position within Baxter’s regulatory team.