Job Title: Qualified Person (w/m/d)
Contract: Permanent
Salary: Negotiable
About the Role
I am currently working with a wholesaler in Bayern region and seeking a Qualified Person (QP) under §15 AMG in Germany to join their Quality team in a GDP and GMP-regulated environment. This is an exciting opportunity for a recently qualified or experienced QP to take on a role that blends strategic oversight with hands-on operational responsibilities.
As part of a growing team of QPs, you will work closely with cross-functional teams to ensure compliance with regulatory requirements and contribute to our mission of maintaining the highest standards in pharmaceutical quality.
Your Responsibilities;
* Serve as a Qualified Person under §15 AMG for the certification and release of medicinal products.
* Oversee and ensure compliance with GDP and GMP requirements across all operations.
* Collaborate with the quality assurance and operations teams to manage deviations, CAPAs, and continuous improvement initiatives.
* Engage in operational tasks, including supporting packaging and wholesale operations, while ensuring adherence to regulatory guidelines.
* Support audits, inspections, and training sessions to maintain regulatory readiness.
Requirements;
* Qualifications: A life science degree and certification as a Qualified Person under §15 AMG in Germany. Newly qualified QPs are encouraged to apply.
* Experience: Practical knowledge of GMP and GDP environments. Experience in the pharmaceutical packaging or wholesale industry is an advantage but not mandatory.
* Skills: Strong fluency in both German and English (C-level proficiency).
* Teamwork: A collaborative mindset to join a team of two existing QPs, becoming the third member of this key group.
* Flexibility: There is some flexibility for home office option but this is primarily an on-site role.