Section Head - QA - Sterile

Job description

Job Purpose Direct and develop compliance to global and in-house quality standards to ensure that quality operations at siteconsistently achieve quality objectives of organization. Key Accountabilities • Monitor and conduct internal inspections to evaluate adherence to cGMP and in-house standards as perprocedures • Conduct internal inspection • Monitor the execution and closeout of internal inspections as per schedule • Submit inspection report and checklist to unit QA • Review the acceptability of compliance provided against the observations by units • Evaluate trainee inspectors for certification purposes • Provide assistance to corporate audit team in the form of document availability and justifications in lieu ofobservations • Monitor updates of Unit SOPs to establish robust quality system to meet current regulatory requirement and cGMP • Review the list of identified procedures that need to be updated • Monitor and review the updating of SOP monthly • Review the quality of SOPs recommended by team • Monitor closure of change request raised by user for updating SOPs • Review the comments provided by users on corporate procedures (QA and QC) for acceptability and sharethe same with CQA • Control the system to analyse QMS documents for completeness and accuracy in line with cGMP requirements • Review quality agreements with service providers to define the standards and responsibilities of ContractGiver/ Acceptor • Deliver trainings on basic QMS systems to ensure adherence to cGMP requirements • Understand requirements/ pre-requisites for implementation of software to prepare the implementation plan • Monitor units to seek fulfilment of the plan • Review and identify gaps between regulatory expectations as communicated by corporate and site levelpractices and communicate the status to the corporate team