Descripción de la vacante
The main responsibilities are to :
Participate in NPI projects defining the Customer requirements for these specialized areas.
Prepare the User Requirements Specifications for Sterilization, Microbiology, Cleanroom and Laboratory Testing.
Elaborate and execute Validation Protocols and Reports applicable for these areas (Sterilization Process Validations, Clean-
rooms Validations, Environmental Monitoring Systems Validation, Monitoring Equipment Validations, Water System Validation, Cleaning Validations, Analytical Methods Validations).
Update the Quality System Documentation and New Document Creation to be aligned to Customer and Regulation requirements for Sustaining.
Implement new Lab testing required.
Lead and follow up on Special Projects with Sterilization and Lab Services Suppliers.
Lead and participate in new projects preparation and presentation to the Management for Improvements and cost reduction.
Participate and support during third parties audits such as corporate ISO & FDA Audits.
Ensure GMP, ISO, QSR Regulations and Standards are followed.
Perfil del candidato
Degree in Science with major in Biology or Chemistry. At least 5 years of experience in Sterilization Processes, Clean-room Monitoring / Standards and Laboratory Testings.
Results driven, good interpersonal and organizational skills, proficient and ability to solve problems. Fluent English and availability to travel.
Oferta de empleo
Benefits above law
Attractive compensation package