Team Member DP - QMS and Material Management

Job Summary

We are looking for a candidate to oversee manufacturing and production operations, managing equipment, process validation, handling change controls, deviations, incidents, and ensuring compliance with regulatory audits. Responsibilities include creating SOPs (Standard Operating Procedure), providing training, and applying expertise.

Roles & Responsibilities

• You will be responsible for handling line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing.

• You will be responsible for handling equipment like Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water system, compressed air, Nitrogen system, etc.

• You will be responsible for process validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.

• You will evaluate change controls, deviation, and incident, (OOS) out of specification, (OOT) out of trend, and risk management.

• You will prepare the production process SOPs (Standard Operating Procedures) and batch records.

• You will provide training on GMP (good manufacturing practices).

• You will apply knowledge of aseptic processes, Lean, OEE (Overall Equipment Effectiveness), and similar KPIs (Key Performance Indicators).

• You will respond to queries and questions regarding regulatory audits such as US FDA (Food and Drug Administration).

Function: Other
Experience Level: Mid-Senior Level