In this role, you will have the opportunity to:
61 Implement contamination control & sterility assurance actions at site
61 Participate in global CCSA community, perform site assessment, learn best practices and lead site improvement
61 Ensure master set testing and documentation per plan for product claims:
a) Plan master set testing for all site products;
b) Ensure production orders for master set samples are released on time;
c) Send master sets to respective testing and irradiation locations;
d) Track sample status and collect test results;
e) Document test results for product claims.
61 Answer customer inquiries and audit questions on product cleanliness & sterility.
61 Support site projects, initiatives, and external audits.
The essential requirements of the job include:0202
61 Bachelor or Master in a scientific field, preferable in Life Sciences, e.g. bio, biomedical, chemistry, chemical, pharma, …02
61 Minimum five years of relevant experience in pharmaceutical, medical device or other regulated industry
61 Willing to collaborate with cross-functional team toward a common goal
It would be a plus if you also possess previous experience in:
61 Track record of working in a cleanroom environment
61 Certified internal auditor for ISO 13485
61 Project management experience