Job Description
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
Positive process knowledge of Injectable processes
Designing of Master Batch Records (MBRs) in PASIX, ESP, GMBR, PVL,



and PMBR based on MPR/PIS/MPC for recent 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.

📌 Team Member Documentation Pydibimavaram
🏢 Dr. Reddy's Laboratories
📍 Pydibimavaram