Works with other departments to ensure the quality of products and compliance to internal procedures and external standards. Provides quality oversight to GMP processes through walkthroughs and review of executed batch records and associated documentation, and review of analytical data. Continuously improves quality system procedures related to these tasks.
•Bachelor’s degree in relevant scientific discipline
•Minimum three years of experience in pharmaceutical, biotech or medical device industry with some experience reviewing manufacturing batch records
•Excellent organizational skills and attention to detail
•Good verbal and written communication skills
•Strong interpersonal skills
•Computer literacy, proficiency in MS Office, Excel, PowerPoint etc.
•Ability to work independently and effectively collaborate with others
•Working knowledge of FDA and international regulations and GxP guidelines