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.
