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

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.

What you'll be doing

Complaint Management:

• Be Local Complaint Coordinator (LCC).
• Notify the authorities of all reportable Complaints.

Field Action Management:

• 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.

Training:

• Train employees (including new SOP's), ensure training records are maintained and archived.
• Assure that distributors, suppliers and service providers are trained on Baxter requirements.

CAPA Management:

• Manage Non-Conformity Reports and CAPA.

Release of Products:

• Perform release of products for distribution in accordance with the applicable procedures and local requirements.

Selling Authorization:

• Perform selling authorization in accordance with the applicable procedures for Turkey.

Regulatory document and submission:

• 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.

• 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.