Qualified Person for Distribution / Quality Assurance Specialist

Qualified Person for Distribution / Quality Assurance Specialist

The Qualified Person for Distribution is responsible for ensuring the correct distribution of medicines , including compliance with Good Distribution Practice (GDP) and legislation.

The Quality Assurance Specialist is responsible for maintaining, improving and ensuring the correct interpretation of the GMP/SDP, resolving problematic and innovative situations within the company within the GMP/SDP, working with colleagues across the company to resolve them.

Tasks:

Overseeing Good Distribution Practices (GDP):
Ensuring that all distribution processes (warehousing, handling, transportation) meet the requirements of the GDP and other relevant regulations.

Reporting to the State Institute for Drug Control (SÚKL):
Inventory reporting (OOP and Na výzvu), DIS-13 reporting for Orifarm Supply s.r.o.. and other Orifarm entities.

Quality assurance of distribution, maintenance of quality system:
Control and supervision of quality of medicines in the distribution chain, including compliance with storage conditions. Maintaining and updating the quality system to ensure compliance with the GDP. Collaborating on the Pharmaceutical Quality System Review.

Management and supervision of warehouse processes:
Reviewing warehouse and logistics processes to ensure proper handling and storage of pharmaceuticals. Collaborating on the implementation of new processes and improving existing processes.

Reviewing and approving documentation:
Creating, reviewing and approving controlled documentation related to distribution and company processes. Regular updating of the Distributor Questionnaire.

Communication with relevant authorities and partners:
Communication with the State Institute for Drug Control (SÚKL), other authorities and foreign distribution partners. Contact person for SÚKL - distribution department.

Conducting audits:
Conducting internal and external audits focusing on GDP and quality system compliance.

Participation in audits:
Attendance and cooperation in inspections and customer audits.

Conducts the re-release of returned MPs to the markets Decides on the final disposal of returned, rejected, recalled or counterfeit products.

Resolving deviations, participating in change procedures, creating risk analyses, CAPA management
Both for the distribution department and for other activities carried out in the company. Ensures resolution in accordance with GMP/GDP rules.

Requests for distribution of vaccines, blood. derivatives and allergens to European drug authorities.
Collaboration with qualified persons of the LP manufacturer.

Monitoring of current legislation, self-education:
Maintaining knowledge of current legislation in the field of distribution of pharmaceuticals and communicating news/information to colleagues. Participation in training sessions.

Other:
Performing other tasks and activities as directed by supervisor, collaborating with colleagues from QA/QP team, other departments of Orifarm Supply s.r.o.. and other Orifarm entities.

Required education and knowledge

Completion of an accredited Master's degree program in Pharmacy or an accredited Master's degree program in General Medicine or Dentistry, or an accredited Master's degree program in Veterinary Medicine or an accredited Master's degree program in Veterinary Hygiene and Ecology, or in Chemistry and/or Biology.

Knowledge of AJ at a communicative level.

PC user skills.

Knowledge of legislation related to parallel import, production and distribution of LP and pharmaceuticals in general.

Deeper knowledge in the areas of GMP and SDP.

Communication, independence, ability to work in a team, decision making skills, attention to detail, ability to work with data, diligence, consistency, flexibility, responsiveness to company needs.

BENEFITS: Pension insurance, Benefit card, 13th salary, 5 weeks of vacation. Mobile and notebook. We provide catering in our canteen, ensuring drinking conditions.