Job Description

Qualified Person

Location: Hungary
Contract Type: Permanent

• Join a trusted logistics partner committed to driving scientific advances and improving quality of life through exceptional clinical trial services
• Contribute to the discovery of life-changing treatments by ensuring compliance with pharmaceutical regulations and GxP standards
• Benefit from a flexible work arrangement with 3 days of remote work per week

Our client, a well-established pharmaceutical company, is seeking a highly skilled Qualified Person to oversee their activities in Hungary. This is an exciting opportunity for a professional with a passion for supporting vital medical research to make a meaningful impact on society.

Position Overview

As the Qualified Person, you will play a crucial role in ensuring compliance with pharmaceutical regulations and GxP standards for our client's operations. Your expertise will be instrumental in maintaining the integrity of the supply chain, enabling the successful execution of clinical trials and the development of groundbreaking treatments.

Responsibilities

• Perform the duties of the responsible person as outlined in Regulation 39/2004 (IV.26) ESzCsM
• Oversee pharmaceutical wholesale, manufacturing, and clinical trial logistics activities to ensure compliance with applicable laws, regulations, and GxP principles
• Develop, approve, and review Standard Operating Procedures (SOPs)
• Manage regulatory permits and liaise with the competent authority (NNGYK)
• Supervise storage conditions, production, and packaging operations
• Develop and implement quality assurance systems and standards
• Investigate non-conformities, manage Change Control and CAPA processes
• Conduct supplier audits and prepare audit reports
• Organise GMP training programs

Requirements

• Relevant higher education degree in pharmacy, quality assurance, or a similar field
• Minimum of 3 years of quality assurance experience in the pharmaceutical industry
• Previous batch release experience as a Qualified Person is essential
• Proficiency in applying GMP regulations
• Thorough knowledge of regulatory requirements and GxP standards
• Experience in ensuring compliance with ISO 9001:2015 standards
• Excellent problem-solving and documentation skills
• Fluent English communication skills, both written and verbal - at least B2 level