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 of observations
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 share the same with CQA
Review quality agreements with service providers to define the standards and responsibilities of Contract Giver/ 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 level practices and communicate the status to the corporate team
Qualifications
B. Pharma/ M.Sc
Relevant Work Experience
Minimum experience of 5-8 years in Pharma and 1 year as a team lead
