Quality Assurance Specialist

DEVA Holding A.Ş.

A member of the East Pharma Group, Deva Holding has been at the forefront of pharmaceutical industry in Turkey for more than 60 years, using a wide range of pharmaceutical technologies to develop quality medicines for serious and life-threatening diseases. Deva Holding employs more than 2000 people at operation sites in Istanbul, Kartepe and Çerkezköy. Our commitment to R&D is reflected by our large R&D center in Çerkezköy, near Istanbul where more than 150 scientists develop Pharmaceuticals and Biopharmaceuticals according to national as well as EMA and FDA standards. Please take this opportunity to learn about Deva where we believe that our employees are our most important asset & in addition to numerous development opportunities and attractive remuneration, you can expect a great place to work.

We are looking for a talented Specialist to become a part of our young and highly motivated biotechnology development team. Focused on mammalian cell culture based recombinant protein production technology we are committed to the development of Biopharmaceuticals especially Biosimilars. You will have the opportunity to work within an inspiring and challenging environment using state-of-the-art technologies. 

Candidates are required to send a complete application, including an application letter describing their motivations and appropriateness for this position.

For this position, we are looking for an enthusiastic person with a Masters level degree and professional training with a background in Chemistry, Biology or related scientific qualification. At least three years of experience in the pharmaceutical industry, especially in the area of Quality Assurance is desirable.

As an ideal candidate, you have experience in Quality related topics and fulfill the following criteria:

•  Proficient in cGMP regulations
•  Proficient in documentation control, change and deviation management
•  You excel in a demanding interface role in a complex environment and have a solution oriented       mindset as well as good stakeholder management skills across all hierarchy levels
•  Highly organized and capable of running a number of duties in parallel
•  Meticulous record keeping and organizational skills are critical
•  Self-motivated, pro-active, responsible, strong analytical thinking, result-oriented and an excellent team     player
•  Excellent communication and negotiation skills in Turkish and English are desired
•  SAP experience is a plus
•  No military obligation for male candidate

To add additional capacity and expertise to our biopharmaceutical drug development team in Çerkezköy, near Istanbul, we are immediately looking for a Quality Assurance Specialist to ensure that Deva procedures, applicable regulations and standards (Turkish MoH, EMA&FDA) are followed during development and manufacturing of biopharmaceuticals.  

JOB DESCRIPTION

In this position, you will be responsible for: 

• Support and enable our team to fulfill Deva quality standards, implementation and follow-up of quality related activities for data integrity, equipment qualification, GLP-like documentation of experiments as well as in all other quality aspects within the area of responsibility.
• Ensure compliance to the quality and regulatory requirements and the proper documentation of all activities
• You are the quality responsible person for Documents: Support team members and equipment qualification group, review and approve documents, templates and records to ensure quality and compliance
• Change and Deviation management
• Lead and/or support special projects or initiatives in the area of Quality
• Permanently optimize processes in order to increase quality and efficiency standards
• Furthermore you are involved in the SAP purchasing process for the Biotech R&D group, responsible for creation of orders, follow-up and first contact to suppliers