Team Member - Documentation

Job Description:

Responsibilities

• Preparation, review and approval of 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 of Master Production Records (MPRs) such as:
• Master Formula Record (MFR)
• Manufacturing Instructions (MI)
• Production Order Raw Materials (PORM)
• Good process knowledge of OSD and semi solids processes.
• Good Expert in MES - PASIX Design and troubleshooting 
• 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.
• 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:
• Coated, Core, Blend, Enteric, Sub Coating and Drug Loading
• Creation of reservations in SAP.
• Inter and intra communication for sending BOM messages to CFTs.

Qualification & Experience

• B.Pharm/M.Pharm/M.Sc
• MES Design Exposure good to have