- 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.
- Valuable 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

📌 Copy of Team Member - Documentation (India)
🏢 Monster - xshruthix
📍 India