CQA

Job description To prepare and review CSV documents To ensure 21 CFR Part 11 and other regulatory compliance for computerized system To perform gap assessment/risk assessment of existing and new computerized system and provide remedial action plan for compliance To carry out audit of IT systems/ Software Vendor to ensure regulatory compliance To prepare corporate guidance/policies related to computerized system To proactively identify emerging cGMP related informatics trend and implementation as required To do informatics intelligence and do the evaluation and gap analysis to improve quality systems