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