Quality Assurance Manager - Pharma

Yoh is seeking a

• Establish and maintain all aspects of a GMP quality system
• Establish operational SOPs and procedures
• Review and approve SOPs, procedures, master and executed batch documentation, protocols and reports
• Review all documentation for release of APIs for use in non-clinical and clinical studies
• Establish and implement training program for staff
• Establish and implement a Supplier Qualification System
• Establish and implement raw material and packaging component program
• Establish and implement change control, deviation, CAPA, and complaints programs
• Establish and implement internal and external audit programs
• Establish and implement qualification programs for facility, equipment, cleaning, analytical methods and computer systems
• Establish and implement utilities and environmental control programs
• Establish and maintain risk analysis program
• Maintaining and ensuring compliance to cGMP as they pertain to the manufacturing, packaging, labeling, testing and storage of APIs

• Bachelor's degree in a Life Science discipline or equivalent
• Minimum of 5 years of quality experience in quality assurance
• Strong GMP knowledge and experience of current requirements of FDA and ICH guidelines as they pertain to APIs
• Experience in preparation and managing quality controlled documents and quality systems
• Ability to work independently and complete assignments, meet deadlines and time schedules
• Possess excellent written and verbal communication skills and ability to interface with different departments, skill levels, and external personnel
• Excellent analytical and problem-solving skills
• Demonstrate an ability to work as part of a team and possess an excellent work ethic