Ready to make an impact on quality beyond our walls? As Qualified Person, you will safeguard compliant medicinal product distribution and provide quality oversight across our external warehousing, logistics and customer network.
The Qualified Person establishes, describes, and documents the medicinal product distribution system, releases returned goods back into distribution, coordinates recalls, and decides on disposal.
Step into a high-impact regulatory role where you’ll safeguard the timely availability of medicines, own the end-to-end GDP quality system, shape a new 3PL partnership, and collaborate within a truly international team.
KEY RESPONSIBILITIES AND ACTIVITIES
- Control and completion of documentation, control of transport conditions, GDP distribution relase for products, already GMP certified by other EU QP
- Prepare, review and approve Quality Assurance Agreements
- Review and approve risk assessments, change controls, deviation and complaints investigations and their associated CAPAs
- Support investigation process to ensure the timely evaluation of deviation and complaints and their escalation when needed
- Edit, review, approve GMP and GDP documents and internal procedures
- Review and approve Product Quality Reviews
- Working with electronical systems (e.g. Quality Forward, eDMS, SAP)
- Registration of approved suppliers/distributors and relevant GDP certificates
- Single Point of Contact for the Local Health Authority in relation to Zentiva k.s. distribution activities
- Support internal, external, customers audits and lead / assist during Health Authority Inspections as required
QUALIFICATIONS & REQUIRED SKILLS
- University degree with specialization in chemistry, industrial chemistry, biochemistry, or pharmacy
- At least 5 years experience in quality area in pharmaceutical industry
- Strong knowledge of GMP and GDP processes and regulations, pharmaceutical quality assurance principles and regulatory requirements
- Experience with deviations, complaints, investigations, CAPAs, change controls, risk assessments, quality agreements, transport/storage excursions and audit/inspection support.
- Excellent analytical problem solving skills
- Flexibility and ability to manage competing priorities
- Effective communication and negotiation skills
- Collaborative, team-spirited, positive, and energetic person
- Fluency in Czech and English proficiency level are mandatory
WHY ZENTIVA
At Zentiva, our values guide the way we work every day: Accountability, Authenticity, Collaboration, Courage and Trus t. We believe that great results come from people who take ownership, work together and are ready to make a difference.