Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in haematology, immunology, neurology, and transfusion medicine.

We're looking for a Quality Manager and QP to join our team in Turkey.

Role Purpose: 

According to the requirements of the country legislation and to Corporate quality policies and guidelines, he/she is responsible to guarantee an efficient Quality System in the legal entity. Supports Global Quality on the activities necessary for the release. Assures the level of quality on the distribution of the products. Release the products for the local market.

Main Responsibilities:

• Acts as the QP/RP for Kedrion Betaphar Turkey
• Ensures the establishment, implementation and maintenance of the quality management system according to the regulations at local level.
• Ensure systematic communication with the Global Quality Functions and the correct transposition of Global Policies and Global Procedures at local level.
• Focuses on the management of delegated activities and the accuracy and quality of records.
• Ensures country batch release process is established.
• Release the products for the local market.
• Decides the final status of returned, rejected, withdrawn or counterfeit products.
• Approves any returned goods which will be transferred to saleable stock.
• Ensures that the medicinal products are distributed in accordance to GDP:
• Ensures that the Quality System operated by distributor guarantees that medicinal products distributed are authorized in accordance with local legislation, that storage conditions are always observed, including during transportation, that contamination from or of other products is avoided, that an adequate turnover of the stored medicinal products takes place and that products are stored in appropriately safe and secure areas. 
• Responsible for assessment of complaints, deviations and changes within the Kedrion business process in country affecting all quality issues in customer care (e.g. product recalls, deviation in storage conditions) and logistics (e.g. batch release etc.).
• Coordinates the recalls of products and ensures that they are carried out promptly.
• Ensure that customer complaints are dealt with effectively.
• Ensures that internal audits are carried out at appropriate intervals according to a prearranged schedule.
• Prepares, participates in and follows-up internal self-inspections and external business partners (Warehouse).
• Provides support and follows up the inspections.
• Provides approval of suppliers and customers.
• Approves all kinds of activities made by the service provider that may be related to GDP.
• Keeps a proper record of delegated tasks.
• Ensures the implementation and maintenance of training programs.
• Provides regular training sessions and updates to Kedrion staff to increase understanding of the GMP/GDP and SOP requirements and implementation of best practices.
• Ensure that the right products are delivered to the right addressee within a satisfactory time period.
• Generates and maintains reports of quality complaints.
• Supports necessary activities in order to participate and win to national, regional and hospital tenders.
• Responsible for checking and approving label of products, import dossier, licenses of the company, and dealing with Kedrion sales associate.
• Keeps abreast of the local legislation, guidelines and customer practices in all countries that the company exports to.
• Participates in and represents the company’s interest at relevant events organized by country pharmaceutical associations.

Requirements:

• Professional experience in related fields of at least three years.
• Professional experience in quality management in pharmaceutical industry.

• Written and spoken fluency in Turkish and English.
• Education: university studies degree in the field of pharmacy
• Place of residence: Turkey