Job Details

* Bachelors degree in chemistry, biology, chemical engineering, or related scientific fields.* 1 - 3 years experience in a GMP chemical manufacturing environment or related industry* Knowledge and experience with GMP associated with manufacturing APIs and excipients (ICH Q7 and IPEC/EXCiPACT specifically).* Ability to read, understand, and execute procedures and process instructions.* Ability to read and understand required standards and translate them to site procedures.* Ability to receive safety and process training.* Ability to participate and contribute to zero-incident culture and the facilitys safety and quality culture to maintain and improve the safety of employees and products.* Strong attention to detail and data analysis skills* Ability to effectively categorize quality complaints and lead incidents to closure* Excellent communication skills.* Strong organizational and documentation skills and attention to detail.* Ability to thrive in a multinational and multicultural environment.* Strong knowledge of FDA cGMP operations, requirements, and safety programs.* Familiarity with SAP or similar ERP systems.* Proficient knowledge of ICH/FDA and ISO requirements, as well as IPEC/EXCiPACT guidelines and standards* Strong computer skills; Microsoft Office applications & iLIMS or similar Quality database.

#J-18808-Ljbffr