Le poste
04As a member of our great Quality Control team, you will be responsible for the routine execution of various biochemical methods, focusing on ELISA, qPCR, ProA and enzyme assays, while adhering to GMP and safety guidelines.
01Preparation of qualification, calibration, maintenance plans in line with GMP and regulatory requirements. (IQ, OQ, PQ) according to guidelines and procedures.
02Verify proper installation of instruments (SpectraMax, qPCR, ViaCell etc.) according to manufacturer specifications and GMP standards.
03Validation of SMP Templates Performing ERAS and DIRAS according guidelines.
04Ensure all qualification data is accurate, complete, secure, and compliant with data integrity principles
05Ensuring communication with the responsible QUS, IT, QA and QC employees.
06Awareness of software lifecycle management, including validation, updates, patches, and version control, ensuring continued compliance with GMP requirements.
07Knowledge of electronic data capture, storage, backup, and retrieval processes to ensure compliance with data integrity principles (ALCOA+).
08Ability to interpret system logs, error messages, and diagnostic tools to identify and resolve software or hardware issues during maintenance and qualification
09Ensure ongoing compliance with GMP through audits and continuous process improvements.
10Familiarity with regulatory guidelines relating to computerized systems in GMP environments, such as FDA 21 CFR Part 11 and EU Annex 11.
11Understanding of how instruments/robots interface with Laboratory Information Management Systems (LIMS) or other relevant platforms.
