Job Description

• Handling of Quality management system (QMS) documents i.e Change Control, Deviation, Incident, Process Validations and Corrective Action and Preventive Action(CAPA) for production as per respective SOP.
• Preparation, Review and Revision of SOPs of  Production department as per respective procedure.
• Risk assessment for various activities performed in manufacturing area.
• Preparation and Review of Batch Manufacturing Record (BMR).
• To coordinate with Engineering & Quality Assurance departments during installation of new machines in the respective area.
• Preparation of URS of various equipments, instruments and machines.
• Knowledge related to Annual Product Quality Review (APQR).
• Must have experience related to SAP software and MS Office.
• Knowledge of Media fill, Sterilization techniques (moist heat sterilization) and other basics of Parenteral formulation manufacturing.