Quality Assurance & Regulatory Affairs Specialist – Pharma

Baxter Healthcare; Fatih; On-site; TRY 350,000 - 550,000; Full time

Job summary

Baxter Healthcare is seeking a Quality Assurance and Regulatory Affairs Specialist in Istanbul to ensure compliance across complaints, CAPAs, and product registrations. You will coordinate regulatory submissions, support launches, and maintain licenses throughout the product lifecycle.

The role requires a bachelor’s in Pharmacy, Chemistry or Chemical Engineering, with at least 2 years in QA/RA in pharma or medical devices, and strong English and cross-functional collaboration skills.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, or Chemical Engineering.
• At least 2 years in QA or regulatory affairs in pharma/medical devices.
• Experience as delegated QP preferred.
• Knowledge of GMP, GDP, ISO 9001, ISO 13485 preferred.
• Excellent English, strong communication and problem solving.

Responsibilities

• Coordinate local complaint handling and notify authorities.
• Lead field actions and maintain training records.
• Manage CAPA and product release activities.
• Develop regulatory plans and support product launches.
• Ensure regulatory documentation meets timelines.
• Maintain product registrations throughout lifecycle.

Skills

English fluency

Cross-functional teamwork

Communication skills

Problem solving

Independent work

Education

Bachelor in Pharmacy

Chemistry

Chemical Engineering

Tools

Word

Excel

PowerPoint

Outlook

ERP systems

Job description

Baxter Healthcare is seeking a Quality Assurance and Regulatory Affairs Specialist in Istanbul to ensure compliance across complaints, CAPAs, and product registrations. You will coordinate regulatory submissions, support launches, and maintain licenses throughout the product lifecycle.

The role requires a bachelor’s in Pharmacy, Chemistry or Chemical Engineering, with at least 2 years in QA/RA in pharma or medical devices, and strong English and cross-functional collaboration skills.