Section Head - QA Validation - 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