promeatherapeutics
Key Responsibilities: Responsible for review of stability protocol & report. Responsible for Preparation of Annual Product Quality Review. Responsible for review of Master Packing Card & Master Formula Card. Responsible for preparation and review of Process validation Protocols and reports. Responsible for review of Batch Manufacturing and Batch Packing records Responsible for preparation of batch release certificate and ensuring batch release process performed as per the SOP. Responsible for issuance of Formats, Logbooks, Register, protocol, reports, BMRs and BPRs as per respective procedure. Responsible for review of QC documents such as Specifications and Standard Testing Procedure (RM, bulk, finished product, RST). Responsible for review of COAs (Raw Material, Packing Material & Finished Product).
Sound knowledge of cGMP, GLP, and data integrity principles. Experience in review of analytical data generated through HPLC, GC, UV, IR, Dissolution, etc. Good understanding of analytical method validation and transfer. Proficient in documentation and good communication skills. Familiar with regulatory expectations (USFDA, MHRA, WHO, etc.).