• To prepare, review and approve SOP’s., Validation protocols and reports. • To execute process validation, cleaning validation, hold time study, packing process validation & transportation validation. • Coordination with cross functional teams for smooth conduction of validation activities with respect to: • Process Validation of new product as well as existing products • Hold Time Study • Packing Validation, Transportation Validation of products • Cleaning Validation • To review and approve CAPA, Deviation & Change Control. • To response the query related to validation. • To ensure that the product meets the defined standards for strength, identity, safety, purity and quality by various system-driven approaches. • To participate various regulatory / customer audits and ensure the compliances of Audit observation. • Any responsibility/additional work assign by Head Quality.