Validation Manager Combination Product (m/f)

REFERENZNUMMER:

318196/11

IHRE AUFGABEN:

-Ensure all projects follow the risk management procedures especially for process FMEA
-Collaborate with all QA representatives to ensure robust process validations are in place
-Actively participate up to facilitating process FMEAs, and ensure GMP documentation are completed for Combination Products
-Serve as the Subject Matter Expert for Process Validation, Design Transfer and pFMEA requirements according to 21 CFR Part 4 of allocated medial devices and combination products

IHRE QUALIFIKATIONEN:

-BS degree in Life Sciences or chemical or mechanical engineering
-Experience in process validation for combination products and capability of applying risk management concepts and tools
-Understanding of combination products and the biotechnology industry
-Knowledge of cGMPs, international regulatory requirements and quality system regulations, and medical device directives, ISO 13485 and ISO 14971 as well as 21 part 210/211
-German and English skills

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist