Atul

Contribute to the success of an innovative organization and work with talented individuals in the manufacturing, engineering, marketing and quality disciplines.
 
 
Executive Profile
 
Over four years’ experience in the Pharmaceutical and Health Care industry utilizing cGMP guidance and FDA regulation to create & market quality products.
 
ü  Participated in numerous successful FDA (CDER and CBER) compliance audits, face-to-face and behind the scenes.
 
ü  Performed numerous Internal, Material Supplier and Third Party Quality Audits.
 
ü  Developed and organized quality documentation systems, (i.e. SOPs, Change Control, CAPA, IQ, OQ, and Process Validation). Hands on validation of packaging and manufacturing equipment.
 
ü  Developed compliance training systems where department managers’ partner in the creation and review of training requirements by job function, and assess individual and department compliance performance.
 
ü  Developed standard training modules and trained employees in the areas of SOPs, cGMP, Cleanroom Technology, Chemical Processing of Active Pharmaceutical Ingredients (API), Solid Dosage Forms, Packaging/Labeling, FDA, FSSI and GMP Regulation.
 
 
ü  Completed the project management duties for dozens of small to intermediate sized capital equipment projects on time and on budget. Most notable the build-out of a Class 100 Cleanroom.