Qualified Person for Quality (Kyiv, UA, 3141)

At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

Our office STADA Ukraine is located in Kyiv, and our manufacturing site is located in Bila Tserkva.

Qualified Person for Quality   

Kyiv | Ukraine (UA) | Full-time | Fix-term

We are looking for an experienced, energetic, and motivated professional to join our team as a Qualified Person for Quality responsible for the quality oversight of imported medicinal products. Temporary position (replacement for an employee during mobilization).

Key Responsibilities:

Prepare and submit documentation for state quality control procedures for medicinal products imported into Ukraine.

Perform incoming quality control of imported products, including sampling and submission of samples to the territorial bodies of the State Service of Ukraine on Medicines and Drugs Control (SSU MDC).

Coordinate laboratory testing of medicinal products and obtain quality certificates issued by authorized laboratories.

Issue and document the Release Authorization (approval for sale) for each batch of imported medicinal products.

Ensure proper support of procedures related to placing medical devices, food supplements and cosmetic products on the market in line with legislative requirements and internal procedures.

Prepare and submit reports on imported medicinal products to state control authorities at the place of business operations.

Provide information to the territorial bodies of SSU MDC on:

identified substandard medicinal products;

medicinal products suspected of falsification, falsified and unregistered medicinal products;

other quality defects or non-conformities.

Ensure compliance with the Emergency Action Plan in line with Ministry of Health orders regarding suspension of import and withdrawal of medicinal products from the market.

Participate in the review and investigation of complaints related to product quality (medicinal products, food supplements, medical devices, cosmetic products).

Inform manufacturers about identified non-conformities during receipt of products at the warehouse.

Ensure timely updates to the license for import of medicinal products.

Ensure timely maintenance and updating of the importer’s dossier.

Develop and coordinate the signing of quality agreements with GxP service providers.

Develop and update Standard Operating Procedures (SOPs) related to the import process, product receipt at the warehouse, incoming quality control, and communication with regulatory authorities and laboratories.

Organise and support external and internal inspections.

Contribute to the effective functioning of the pharmaceutical quality system.

Candidate Requirements:

Higher education.

At least 2 years of experience in this role.

English – Upper-Intermediate level.

We Offer:

Work in a fast-growing international company.

Official employment and full material and technical support.

Competitive salary and transparent bonus system.

Health and life insurance.

Support of mental health and well-being of employees and their families.

Opportunities for career growth and professional development.

Opportunities to study foreign languages.

Are you looking for new challenges where you can make a difference for people’s health? We are looking for candidates with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team. We would be pleased get to know you. Please use our online job portal to submit your application: https://jobs.stada.com

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