The QA Manager, Technical Services of 3rd Party U.S. Quality provides Quality and Compliance oversight of third party contractors and external partners for distribution in the U. S. market.
1. Handles day-to-day Quality responsibilities for assigned products manufactured by 3rd party suppliers and distributed in the US
2. Performs batch record review and release for 3rd party manufactured products
3. Reviews and approves Deviations, Investigations and Change Controls associated with 3rd party manufactured products
4. Ensures Stability Management, and Retain / Reserve Sample management systems are in compliance for 3rd Party manufactured products
5. Supports tech transfers, validations and product launches by performing the quality review and approval of process validation protocols and reports, method validation protocols and reports, specifications and test methods, and raw material, component, and product specifications
6. Performs the review and approval of labeling and packaging specifications
7. Supports the Quality department with revision of Standard Operating Procedures
8. Keeps abreast of industry regulations and cGMP trends. Stays informed of FDA and ICH Guidelines related to GMP (Commercial and Development)
This role is being handled by Olivia at Meet, full details are available upon application and you can contact Olivia Fico on email – firstname.lastname@example.org or reach her on the phone at Meet HQ on 646 822 2197.