Vida Arya

Background

About Vida Arya

Over twenty (20) years experience in Pharmaceutical / Biotech industry using Equipment/systems, from cell culture, purification to completion of the end of production. Hands on Knowledge, in all aspects of equipment/system Validation.* Extensive experience in interpreting and implementing policies and procedures resulting from the following industry standards and/or regulations; ASTM, E2500, Q7,Q8,Q9,Q10,(cGMP) 21 CFR Part 11, 210, 211, 806, 820, ICH, HIPPA, ISO 13485: 2003, GAMP4,5.* Hands on experience in validation and commissioning of cGMP regulated Facilities, Utility Systems, Cleaning validation (CIP), Process Equipment Validation and SIPs.* Experience in preparation of compliance related documentation: the Part 11 of 21 CFR assessments, risk assessments, software and equipment specifications, Standard Operating procedures, and validation protocols.* Extensive experience in managing of Validation team (full time and consultants).* Expertise in quality compliance, inspections readiness and approval process for FDA, TGA and EMEA.* Experience in Quality Assurance and quality compliance area. Certification and expertise in Project Management field.* Experience in Track wise, Maximo and EDMQ.