(m/f)

About the role

We are looking for a Qualified Person (QP) to take responsibility for medicinal product batch certification and release and contribute to the development, maintenance and continuous improvement of our Quality Management System. This role combines the assessment of batch documentation with quality oversight, risk management and audit coordination, ensuring compliance with Good Manufacturing Practice (GMP), applicable legislation and relevant quality standards.

Key responsibilities

• Reviewing and evaluating manufacturing and analytical documentation for individual medicinal product batches
• Assessing batch acceptability and compliance with the relevant marketing authorisation
• Performing QP batch certification and release activities in accordance with applicable EU and national requirements, partner agreements and internal procedures
• Ensuring compliance with applicable US FDA requirements for relevant products and activities
• Identifying and investigating deviations, proposing corrective and preventive actions (CAPA) and overseeing their implementation
• Developing, implementing and maintaining the Quality Management System to reduce risks associated with product and service quality and minimise the costs of poor quality
• Preparing, reviewing and implementing internal quality policies, procedures and other quality documentation
• Managing quality system activities and ensuring compliance with relevant legislation, guidelines and standards
• Establishing, maintaining and coordinating risk management processes, including quality and business risks
• Coordinating and participating in internal audits and management reviews, and coordinating external audits of the Quality Management System
• Coordinating audits of new and existing suppliers of materials and services related to the manufacture and wholesale distribution of medicinal products and active substances
• Ensuring company and client readiness for regulatory inspections and audits by certification bodies, customers and suppliers
• Leading and contributing to complex multidisciplinary projects
• Preparing detailed analyses, reports and other technical documentation within the scope of the role
• Performing other related duties assigned by the line manager

Requirements

• Master’s degree, a pre-Bologna university degree or an equivalent recognised qualification in Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry, Technology or Biology, meeting the statutory educational requirements for a QP
• Completion of the scientific subjects required for QP eligibility, with supplementary education where these were not covered by the original study programme
• Minimum 3 years of relevant professional experience, including at least 2 years of practical experience in the qualitative analysis of medicinal products, quantitative analysis of active substances, and testing and checks necessary to ensure medicinal product quality
• The required period of practical experience may be reduced by 1 year for a study programme lasting at least 5 years, or by 1.5 years for a programme lasting at least 6 years; the requirement for 3 years of overall professional experience remains
• Fluency in Slovenian and English
• Knowledge of medicinal product and medical device legislation and relevant quality standards is an advantage
• A high level of professional responsibility, independence and attention to detail
• Strong analytical, organisational and decision-making skills
• Ability to ensure 24-hour availability as required for the QP role

We offer

• A specialist role with responsibility for medicinal product quality, GMP compliance and batch release
• An internationally oriented, professional working environment
• Involvement in complex quality, regulatory and continuous improvement projects
• Support for ongoing learning and professional development
• Close cooperation with colleagues across quality, regulatory and other pharmaceutical disciplines
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To join our quality team as a Qualified Person, please submit your CV and a short motivation message to billeveast@billeveast.com