• Primary duty is to perform data capture from shop floor i.e. manufacturing production records into the validated source system. Serve as the user to the APEX MDE system to enter, verify, override, and approve the data.• Working with MSAT team to recover and migrate the purification downstream records into new ERP system and trained operational personals on that.• Working with MSAT and manufacturing team to update the records for Thyrogen column and membrane lifetime validation studies. Also update the record management procedure and trained manufacturing operators. • Managing access to Batch Record for audit use and data verification.• Assist with preparing, reviewing and controlling documentation required to comply with GMP, FDA regulations and other regulatory agencies as applicable.• Collaborate with other departments such as Engineering, QA and Manufacturing to resolve identified issues.• Assists with obtaining documentation necessary for change controls, deviations and other GMP documents.• Maintain attention to detail while executing multiple tasks.• Manage timelines to meet department goals.• Maintain control and confidentiality of documents and information.

 Supervised various contract companies for electro-mechanical work provided for ADCO staff residences Ensured quality of work, parts/materials provided and prompt response to concerns Evaluated reported failures and action taken by contractors Reviewed and reported on effectiveness of services provided Maintained regular reporting for ADCO management

 Ensured company’s adherence to the ISO 9000 standard Acted as liaison for all units of company, customers and external organizations Prepared company for ISO 9002-2000 certification