● Controlling all the laboratory tests.
● Qualification and validation of tests.
● Chemical and microbial tests.
● Batch control.
● IPQC control.
● GMP control.
Requirements
● Fluent in regulatory affairs.
● Fluent in batch release and control and release of manufacturing and test documentation.
● Fluent in coordinating, preparing, executing, and post-processing inspections by national authorities.
● Hands-on experience in USP, BP, and EP.
● Analytical method validation skills.
● Analytical instrument qualification skills.
● Process validation skills.
● Fluent in stability studies.
● Self-inspection.
● OOS and OOT skills.
