Quality Assurance & Regulatory Affairs Strategist

Baxter International Inc.; Fatih; Sur place; TRY 250 000 - 380 000; Plein temps

Résumé du poste

Baxter International Inc. in Turkey seeks a Quality Assurance and Regulatory Affairs Specialist to ensure compliance across complaints, field actions, CAPAs, product releases, and regulatory submissions.

You will support product registrations and ongoing licenses, coordinate regulatory activities for launches, and train teams on Baxter requirements. Requirements include a bachelor’s degree in Pharmacy, Chemistry, or Chemical Engineering, 2+ years in QA/Regulatory Affairs, and fluent English.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, or Chemical Engineering.
• At least 2 years of professional experience in Quality Assurance and/or Regulatory Affairs in Pharmaceutical/Medical device or relevant industry.
• Experience as delegated QP (Qualified Person) preferred.
• Knowledge of GMP; GDP; ISO9001 and ISO13485 preferred.
• Very good spoken and written English.

Responsabilités

• Be Local Complaint Coordinator (LCC).
• Notify the authorities of all reportable Complaints.
• Be FA Contact Person ensuring Implementation of FAs according to Baxter procedures and applicable regulations.
• Ensure back up for FCA Contact Person in the country are appropriately trained and back up are always available.
• Train employees (including new SOPs), ensure training records are maintained and archived.
• Assure that distributors, suppliers and service providers are trained on Baxter requirements.
• Manage Non-Conformity Reports and CAPA.
• Perform release of products for distribution in accordance with the applicable procedures and local requirements.
• Perform selling authorization in accordance with the applicable procedures for Turkey.
• Develop and execute regulatory plans for the projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.
• Coordinate regulatory activities to support product launches and ongoing commercialization efforts.
• Ensure regulatory documentation is complete, accurate, and submitted within required timelines.
• Maintain product registrations and licenses throughout the product lifecycle.

Connaissances

Quality Assurance

Regulatory Affairs

Quality systems

English (fluent)

Formation

Bachelor in Pharmacy

Chemistry degree

Chemical Engineering degree

Outils

MS Office

Regulatory databases

Description du poste

Baxter International Inc. in Turkey seeks a Quality Assurance and Regulatory Affairs Specialist to ensure compliance across complaints, field actions, CAPAs, product releases, and regulatory submissions.

You will support product registrations and ongoing licenses, coordinate regulatory activities for launches, and train teams on Baxter requirements. Requirements include a bachelor’s degree in Pharmacy, Chemistry, or Chemical Engineering, 2+ years in QA/Regulatory Affairs, and fluent English.