Qualified Person-Radiopharmaceuticals-Bulgaria

Our client is a leading international manufacturer of radiopharmaceutical products, delivering high-quality therapeutic solutions for the diagnosis and treatment of life-threatening diseases. They are seeking a motivated and responsible Qualified Person (QP)to ensure that all products are manufactured and released in full compliance with Good Manufacturing Practices (GMP) and applicable regulatory requirements.

Key Responsibilities

Batch Certification & Release

• Lead and supervise all processes from production start to formal product release.

• Certify each batch of finished product prior to release, verifying all manufacturing and quality control records.

• Issue and archive batch conformity certificates in the official Batch Release Register.

• Ensure each batch is manufactured in accordance with marketing authorisation, regulatory standards, and approved documentation.

Quality System & Regulatory Compliance

• Approve and maintain manufacturing and batch documentation for the legally required retention period (minimum 2 years).

• Support inspections and ensure timely and effective Corrective and Preventive Actions (CAPA).

• Ensure ongoing compliance with quality standards, regulations, and updated legislation.

• Maintain confidentiality of all documents, data, and sensitive information.

Supplier & Material Compliance

• Ensure materials and services impacting product quality comply with approved standards.

• Support implementation of supplier quality assurance processes aligned with the company’s quality system.

Operational & Safety Responsibilities

• Collaborate with the Radiation Safety Officer to ensure production activities follow radiation safety protocols and emergency plans.

• Coordinate investigation and management of customer complaints with internal quality teams.

• Support implementation of an effective pharmaceutical quality management system in line with obligations of the marketing authorisation holder.

Documentation & Reporting

• Prepare and approve SOPs, work instructions, technical agreements, specifications, validation documents, change controls, deviation reports, and complaint records.

• Report safety issues and product reactions to the Qualified Person Responsible for Pharmacovigilance (QPPV).

• Prepare and submit regulatory applications and notifications to national authorities; participate in inspections, renewals, and authorisation processes.

Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmacy or related scientific discipline.

• Valid Qualified Person (QP) certification.

• Minimum 2 years’ experience in the pharmaceutical or radiopharmaceutical industry.

• Strong knowledge of GMP and regulatory frameworks.

• Excellent command of Bulgarian and English.

• Residing in or able to commute to Sofia.

We Offer

• Opportunity to join a well-recognized international group

• Competitive compensation package with performance-based incentives

• Opportunities for professional development and career growth

• A dynamic, collaborative, and supportive working environment

• Exposure to international best practices and cross-functional teamwork

Only the candidates that fulfil these requirements will be considered. Send your CV in English indicating the job reference to: akman.atilgan@conexusrecruitment.com. Only shortlisted candidates will be contacted.