Responsible person QP/RP

Role Description

This is a full-time role for a Responsible Person QP / RP at Billev Pharma East Ltd. located in Ljubljana, with flexibility for remote work.

As a Responsible Person, you will be responsible for conducting activities as per requirement of Article 51 of Directive 2001/83 and Guidelines on GDP (2013/C 343/01):

• Reviewing and evaluating production and analytical documentation of individual batches of medicines.
• Assessing the suitability of batches of medicines and their compliance with marketing authorisations.
• Carrying out activities related to the release of medicines to the market in accordance with EU regulations, US FDA regulations, local legislation, contract provisions with partners, and internal procedures.
• Detecting and analysing deviations and proposing corrective and preventive actions.
• Developing, implementing, and verifying the compliance of the quality management system with the aim of reducing risks related to product quality and reducing costs associated with inadequate quality.
• Participating in the preparation and implementation of internal quality regulations.
• Carrying out activities in the field of quality management system leadership and ensuring compliance with relevant legislation, guidelines, and standards.
• Introducing, maintaining, and coordinating risk management systems, including business risks.
• Coordinating and participating in internal audits and management reviews, as well as managing and coordinating external quality system assessment procedures.
• Managing and coordinating assessments of the quality system of new and existing suppliers of materials and services related to the production of active substances, medicines, and wholesale trade in medicines and active substances.
• Ensuring readiness of clients and the company for inspections by competent authorities, certification bodies, customers, and suppliers.
• Ensuring the preparation, implementation, and execution of adopted corrective and preventive actions.
• Leading and participating in the most demanding project teams.

Work experience:

• 3 years, including at least 2 years of practical experience in the field of quality analysis of medicines, quantitative analysis of active substances, and testing and verification for the purpose of ensuring the quality of medicines. The period of practical experience can be reduced by 1 year if the study program lasts at least 5 years, or by 1 year and a half if the study program lasts at least 6 years.

Qualifications

• Bachelor's degree or higher in a relevant field such as Pharmacy, Chemistry, or Life Sciences
• Previous experience as a Responsible Person QP / RP in the pharmaceutical industry
• Strong knowledge of pharmaceutical regulations and guidelines, including GMP and GDP
• Excellent attention to detail and problem-solving skills
• Ability to work independently and make critical decisions
• Strong communication and leadership skills
• Proficiency in relevant software and systems
• Slovenian resident, fluent in English (both written and spoken)
• Ability to work effectively in a team
• Strong organisational and time management skills

We offer you:

• Employment for an indefinite period (full-time)
• Acquisition of new knowledge and competencies
• Participation in working groups at the European level and collaboration with experts
• Autonomy in performing job tasks
• Organised and flexible working hours, as well as opportunities for personal development

If you meet the requirements stated in the advertisement, please send us your CV, a brief motivational letter, and contact information to the email address [email protected]

For any additional information, feel free to call us at: 051 231 599.

Billev Pharma East Ltd., Tržaška cesta 202, 1000 Ljubljana, www.billeveast.com