Qualified Person (QP) / Quality Specialist – Pharmaceutical

About the role

We are looking for a Qualified Person (QP) and Quality Specialist to join our Dr. Max Own Label team. The role will ensure compliance with EU and Czech pharmaceutical regulations and support the growing quality department across multiple countries.

Key responsibilities

• Ensure full compliance with EU and Czech legislation, including Directive 2001/83/EC, Act No. 378/2007, Decree No. 229/2008, Ph. Eur., and EudraLex Volume 4 (GMP).
• Oversee importation of medicinal products from third countries and verify EU certification and distribution requirements.
• Collaborate on the implementation and maintenance of the Quality Management System (QMS) and Good X Practice (GxP) standards.
• Certify each production batch, maintain a register for at least five years, and ensure batch testing meets marketing authorisation dossiers.
• Report significant quality issues to management promptly and communicate with competent authorities when required.

Required profile

• University degree in Pharmacy, Chemistry, Life Sciences or related field.
• Proven experience in pharmaceutical quality assurance with GMP expertise.
• Qualified Person certification meeting Article 49 of Directive 2001/83/EC.
• Native Czech or Slovak speaker with advanced English proficiency.

Required skills

• Good Manufacturing Practice (GMP) knowledge.
• Understanding of EU pharmaceutical legislation and Czech regulations.
• Experience with Quality Management Systems (QMS) and Good X Practice (GxP).
• Qualified Person (QP) certification.

What we offer

• Competitive salary with yearly bonus.
• Flexible working hours and one day per week home‑office.
• 5 weeks of vacation, meal allowance, Multisport card, transport contribution, and pension insurance.
• Opportunities for professional growth within a leading European pharmacy chain.