Copy of Team Member - Documentation

- Preparation, Review and approval of Standard Operating Procedures (SOPs). - Preparation, review and approval of various protocols and reports, including: - Confirmatory Batch Protocol - Hold Time Protocol - Process Evaluation (Pre-validation) Protocol - Trial Protocol - Process Performance Qualification/Validation Protocol - Stability Protocol - Preparation, Review and approval of Master Production Records (MPRs) such as: - Master Formula Record (MFR) - Manufacturing Instructions (MI) - Production Order Raw Materials (PORM) - Team management and daily work plan assignments and monitoring of daily deliverables inline with the Plan / shopfloor requirements - Good process knowledge of Injectable processes - Designing of Master Batch Records (MBRs) in PASIX, ESP, GMBR, PVL, and PMBR based on MPR/PIS/MPC for new products as well as site transfer products, following SOPs and GMP requirements. - Good decision making skills for - Document circulation to cross-functional teams (CFT), follow-up for review, corrections, and approval. - Creation and modification of Bill of Materials (BOM) and Recipes in SAP. - Follow-up for BOM and Recipe-related tasks for Exhibit, Validation, and Commercial products. - Creation of codes in SAP, such as: - Creation of reservations in SAP. - Inter and intra communication for sending BOM messages to CFTs. B.Pharm/M.Pharm/M.Sc MES Design Exposure good to have Skills: Esp Experience: 0.00-0.00 Years