Responsibilities

• Support Change Controls initiation and end-to-end ownership for Temperature Chambers (Fridges/ Freezers/ Incubators).
• Responsible for Drafting and executing Validation related documents (Validation Plan & Requirement, IOQ/PQ Test Scripts, Summary report, Data Integrity Risk Assessments).
• Responsible for Drafting Operations and Maintenance SOPs.
• Support in generation of Preventive Maintenance program for Temperature Chambers.   
• Coordination with equipment vendor for vendor qualification activities Coordination with different stakeholders’ functions (F&E, QA, QC, Automation, IT).     
• Coordination for Calibration of Temperature Chambers (Fridges/ Freezers/ Incubators).

 Requirements

• Related working experience in biotech or pharmaceutical operation environment is preferred.       
• Strong understanding of various validation approaches, strategies and philosophies.       
• Working knowledge of lab instruments and computerized system validation, controlled temperature chambers qualification etc.        
• Working experience with KNEAT / electronic validation tools are preferred.        
• Experience with change control methodology.       
• Good knowledge in data integrity, GMP and GDP.       
• Ability to facilitate and work in a
• collaborative team-based environment.       
• Team player with strong focus on safety, quality and timeline.       
• Able to work independently with minimal supervision.