- Ensure and GMP Compliance for all LL products at the LL sites.
- To perform routine visits at LL sites as per site visit calendar.
- Supervise the actual manufacturing and testing activities followed at LL site.
- Handling of Raw Materials, Packing Materials, and Semi Finished Products Rejection.
- Handling of Deviation, OOS and Failures of LL sites.
- Review of Market complaint investigation reports for LL products and to ensure closure of the investigation as per the SLA.
- Handling of Product transfer from I&D to LL sites, LL to LL sites, and Own to LL sites.
- Review of Product Compliance and Periodic Evaluation of LL products.
- Review of BMR / BPR (New & Revised) and specifications as and when required.
- Review of stability of data of the products manufactured at LL sites.
- To ensure Pharmacopoeial compliance of LL products at sites.
- Review of monthly report received from LL sites on monthly sites.
- Review of Raw Material , Semi Finished Products, Finished product specifications, and Standard testing Procedure in SAP.
- To perform control sample review of LL Products.
- Review of APQR for all LL Products as per the timelines defined in SOP.
- Any other Quality projects as directed by the supervisor.
Spectrum Talent Management is a forerunner in designing Human Resources solutions specific... to the local needs of our respected clients. Providing services to clients globally our unique implementation methodology has been developed for speedy ramp-up to cater to the ever urgent needs of the industry as well as ensuring that we apply systems, measures and best practice processes in order to meet the demanding SLAs set by our clients. Read full description