The AKKA Technologies Group is a leading international Engineering and Technologies services company scattered in more than 20 countries around the world (Europe, Asia, Africa, America and Middle East) with over 21,000 employees and an annual turnover of 1.5b EUR.
To support the development of our activities, we are now looking for a:
Description of the project:
Translate cGxP and normative requirements (e.g., USP, Ph. Eur., ISO, ASTM) into practical lab processes (e.g. test sample management, test method validation and transfer, discrepancy management and out of specification(OOS), training, change management, complaints) including practical development, testing, implementation, documentation.
This includes in detail:
- Author of protocols, rationales and reports
- Support Change Control activities for Test Methods and Lab Processes
- Execute and support testing activities on medical devices/combination products within cGxP regulated or non GxP area
- Support internal/external Quality inspections of Verification Engineering Labs and help define appropriate responses
- Support the development and completion of robust, risk-based, medical devices / combination products verification strategies.
- Write & review design verification plans, protocols, reports and rationales for justifying chosen approaches (e.g. acceptance criteria, statistical sampling, time points)
- Execute test data analysis (e.g. k-value)
- Support management of unexpected events (e.g., discrepancies, complaints) for medical devices/combination products within cGxP regulated area
- Technical/Engineering degree education or equivalent experience
- Process oriented and analytical thinking
- Experience in characterization of medical device/combination products or packaging is an asset
- Experience of working in Pharma or Medical Device (cGxP, QSR) or other closely-regulated environment (e.g automotive or food industry)
-Good knowledge of legislation, regulation, industry standards and guidance
- Fluent in German and English
If this sound like your next challenge, please send me your updated CV to firstname.lastname@example.org or call me on +41 78 929 78 14 and I will contact you shortly to discuss it further.