Qualification Specialist | Mitarbeiter Qualifizierung (m/w/d)
ABX advanced biochemical compounds
Job Summary
As a Qualification Specialist at ABX, a market leader in PET diagnostic precursors, you will play a critical role in the technical department of GMP production. Your daily responsibilities involve the independent planning, preparation, and execution of equipment and software qualifications, specifically focusing on Design, Installation, Operational, and Performance Qualification (DQ/IQ/OQ/PQ). You will be responsible for creating and maintaining rigorous documentation and coordinating with various departments and external suppliers to ensure regulatory compliance. This role is ideal for a structured professional with a background in chemistry or pharmaceuticals who enjoys technical documentation and process management. The position offers a secure, long-term career path within an expanding international company, supported by a modern working environment and excellent connectivity to the Dresden region.
Required Skills
Education
Completed Bachelor's degree, University of Applied Sciences degree, or University degree in a relevant field.
Experience
- Professional experience in planning and executing qualification processes (DQ/IQ/OQ/PQ) for production equipment.
- Experience in the creation and management of technical documentation within a regulated environment.
- Experience working within GMP or ISO-regulated frameworks is highly advantageous.
- Proven ability to coordinate technical and regulatory requirements with internal departments and external vendors.
Languages
Additional
- Must have a structured and independent working style. Location is Radeberg, Germany, with proximity to public transport (Dresden region).
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