Writing and performing validation of computerised systems according to GAMP 5 and complying with healthcare regulations for computerized systems (CFR Part 11 and Annex 11).Writing and performing validation of GxP regulated Excel spreadsheets.Writing of SDLC (software development life cycle) deliverables- IQ, OQ, PQ, URS, FS, VSR, and RA.Writing software applications reject lists, bug identification, report, and monitoring.Computerised systems management of Periodic Review… Show more Writing and performing validation of computerised systems according to GAMP 5 and complying with healthcare regulations for computerized systems (CFR Part 11 and Annex 11).Writing and performing validation of GxP regulated Excel spreadsheets.Writing of SDLC (software development life cycle) deliverables- IQ, OQ, PQ, URS, FS, VSR, and RA.Writing software applications reject lists, bug identification, report, and monitoring.Computerised systems management of Periodic Review, Annual Report, Raw Data Workflow, and Data Integrity.Implementation of GMP process.Supporting Validation processes for Digital Health according to medical devices regulation (ISO 13485). Show less

Project management for on-time submission to the US market in accordance with specific market and product requirements.Participate in strategic settings of new products development.Working with many interfaces simultaneously (Sourcing, Pharma, Analytical research and development, Quality Assurance, and Quality Control groups).Response to deficiency letters received from the FDA.

Perform quality control testing stability for existing products according to specific market specifications. Accountable for maintaining appropriate documentation (records, lab notebooks, and results) as required by SOPs that comply with cGMP regulations.Application of analytical methods and data analysis using advanced technology systems (HPLC, pH meter, balances)Professional training of new employees.