Job Overview
We are looking for Quality Assurance Specialist to join our Quality Assurance Team in Lüleburgaz, Turkey.

Key Responsibilities

1- Controlling the batch documents and formulas according to cGMP/ISO 9001/ISO 27001, giving systematically approval, archiving, and sending the batch documents to the customers.

2- Investigation and following deviations throughout the company and following their realisation and reporting them periodically.

3- Playing role in teams related with improving the quality and decreasing the deviations throughout the company and contributing the implementation of the decisions taken during the team meetings. Following the implementation and actions of the deviations and change control systems on the site and reporting them.

4- Evaluation of customer complaints, contributing them by investigating, reporting, and giving feedback to the customers.

5- Performing product quality review and determining the corrective and action plan with relevant departments if necessary.

6- Attending GMP/ISO 9001 Quality Management System self-inspections, reporting and following the CAPA plan.

7- Participate in preparation of customer or authority audits to be performed in the facility, attending the audits, preparing the CAPA plan related to the department after the audit and performing the actions according to due date.

8- Contributing to the risk analysis studies during production, analysis, and other processes.

9- Preparing/Revising the standard operating procedures related with the department.

10- Contributing the studies to comply with the department budget and targets.

11- Providing technical support to company personnel for the studies he/she perform.

12- Supporting the preparation and development of ISO 9001, ISO 14001 and OHSAS 18001 quality, environment, occupational health, and safety management systems and performing the applications.

Requirements & Qualifications

• Bachelor’s Degree in Chemistry, Chemical Engineering, and Pharmacy Faculty

• Minimum 3 years of experience in QA department

• Knowledge with GMP and GLP requirements

• Able to use MS Office, LIMS, and SAP effectively

• Upper Intermediate level in English

• Commit to customers, team oriented, results-focused, good communication skills

We chase the miracles of science to improve people’s lives.

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our commitments.

We are one of the largest pharmaceutical companies in Turkey, serving public health for with more than 1,600 employees. Adding value to local economy and development in Turkey, we offer a broad range of products including innovative therapeutic solutions, biotechnological pharmaceuticals, vaccines, and consumer healthcare products.

Our factory in Lüleburgaz is one of the leading pharmaceutical manufacturing plants in Turkey. It is also among the top three Sanofi production sites worldwide in terms of its manufacturing capacity. Our manufacturing site produces high-quality pharmaceuticals in many different forms in accordance with global health standards, and develops generic medicine at its on-site R&D Center.

Pursue progress.

Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles.

So, let’s be those people.

Let’s explore more, and share a purpose, as well as our skills. Let’s reinvent healthcare, chase change, and embrace new ideas. Let’s take bigger risks and find better solutions for the people we help.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.