Quality Assurance Supervisor

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

About the job

Maternity Leave Cover – 1 year

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

​

Job Description:

QMS & Documentation:

• Ensure the implementation of the Applicable Quality Manual in Turkey. This involves the monitoring of the performance of the quality system

• Managing documentation by publishing the documents in TcU and distribute it through TcU and/or by email

• Ensuring all relevant SOP's are in place to meet Corporate Quality Manual requirements as well as all applicable regulations, directives and current Good Manufacturing Practices, Good Pharmaceutical Warehousing & Distribution practices

• Preparation of new SOP's, controlling approval, distribution, obsoleting & filing of quality documents

Complaint Management:

• Be Local Complaint Coordinator (LCC)

• Notify the authorities of all reportable Complaints

• Ensure process and procedures are in place

Country Product Surveillance activity for Medical Devices:

• To ensure effective gathering, recording, transmission to the Product Surveillance team and reporting to the competent Authorities of medical device adverse events

• To collect, follow-up, transmit all local MIR (Manufacturer Incident Report) to MoH in coordination with Post Market Surveillance Team

• To set up and maintain an efficient Product Surveillance system in compliance with the national medical devices regulations and with Baxter standard

Implement Field (FA) actions:

• 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

• Ensure process and procedures are in place

Training:

• Act as the ISOTRAIN Administrator for local Procedures

• Ensure that systems are in place and maintained

• 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:

• 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

Qualifications

The function requires a bachelor's degree in Pharmacy, Chemistry or Chemical Engineering degree in the scientific field.

For a person with the specified education (see above) at least 5 years of professional experience in Quality Assurance in a multinational environment is required.

• Strong Quality management system development and implementation experience

• Experience as auditor /lead auditor

• Experience as QP (Quality Person) is preferrable

• Good Knowledge of GMP; GDP; ISO9001 and ISO 13485

• Ability of understanding country specific regulations and general quality requirements

• Ability to liaise with different functions involved: e.g. PVS, TS, Regulatory

• Very good spoken and written English

• Strong interpersonal, written, communication 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

• The ability to develop in-depth knowledge about products and markets good business sense and a professional manner

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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