QA Compliance Specialist

About the role

We are seeking a motivated QA Compliance Specialist to independently perform control and approval activities for analytical procedure validations, deviations, and qualification projects. The role ensures that all quality‑related documentation meets regulatory standards and supports the continuous improvement of our pharmaceutical products.

Key responsibilities

• Verify that all activities comply with current good practices (cGxP) and data integrity requirements.
• Participate in the development, implementation, and maintenance of the quality system in line with Slovenian, European, FDA, ICH, PIC/S and Sandoz standards.
• Support qualification and validation projects, including planning, consulting and document review.
• Review and approve changes to procedures, specifications and related documentation.
• Investigate deviations and complaints, manage corrective and preventive actions, and track their implementation.
• Prepare for and support internal and external audits and inspections.

Required profile

• University degree in pharmaceutical, chemical or a related natural science field.
• Experience in a laboratory, production, development or quality environment.
• Good knowledge of GMP and data integrity principles.
• Fluent in English and Slovenian with strong communication skills.

Required skills

• cGxP compliance
• GMP knowledge
• Understanding of FDA regulations
• Familiarity with ICH guidelines

What we offer

• Permanent contract with a six‑month probation period.
• Hybrid work model providing flexibility and remote‑work options.
• Annual gross salary range €30,960 – €46,440.
• Annual bonus, vacation allowance, Christmas bonus and share participation.
• Fully funded supplementary pension plan and comprehensive life & accident insurance.