Quality Specialist and Qualified Person
About this role
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Are you passionate about ensuring the highest standards of pharmaceutical quality?
Join Roche Bulgaria as a Quality Specialist and National Qualified Person. In this pivotal role, you will work closely with our Quality Manager within the
License to Operate
team to ensure our life-saving medicines reach patients safely and in full compliance with regulatory requirements.
The Opportunity
As a core member of our Quality team, you will be responsible for the integrity of our Pharmaceutical Quality System (PQS). You will balance technical expertise in batch certification with a proactive approach to quality management, including audits, complaint handling, and data integrity oversight.
Responsibilities
- Batch Certification:
- Certify and release commercial medicinal products and medical devices for the local market, ensuring every batch meets quality, regulatory, and safety standards.
- Quality Oversight:
- Maintain the local PQS in accordance with Roche requirements, ISO 9001, and Bulgarian/EU GDP/GMP regulations.
- Compliance Management:
- Manage unplanned events (deviations, complaints, recalls) and lead corrective/preventive action (CAPA) programs.
- Stakeholder Collaboration:
- Act as the Affiliate Complaint Manager and support the Quality Manager as a backup Data Integrity Steward.
- Auditing:
- Perform self-inspections and GxP audits of third-party distributors, manufacturers, and service providers.
- Who You Are
- You are a detail-oriented professional with a deep understanding of pharmaceutical regulations and a commitment to excellence. You thrive in multifunctional, international environments and possess the technical authority to make critical release decisions.
Requirements
- Education:
- Master’s Degree in Life Sciences (Pharmacy, Chemistry, or Biology).
- Certification:
- Must meet the legal requirements for a
- Qualified Person
- under the Bulgarian Law on Medicinal Products and EU Directive 2001/83/EU.
- Minimum 2 years of experience in Quality Assurance, Quality Control, or Manufacturing within a pharmaceutical company.
- Strong knowledge of GMP, GDP, and ISO standards; fluency in English; and proficiency in ERP/computerized systems.
- Mindset:
- Demonstrates Roche’s core values of Integrity, Courage, and Passion.
About Roche
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.