Description
We are looking for a
Validation Manager Combination Product (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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
- German and English skills
Skills:
- Qualification/validation specialist