Warning letters, 483s, Recalls, Import Alerts, Audit observations
Manage Production activities, ensure GMP compliance and maintain inspection readiness of the Production area always
Monitor and execute the production activities in an area during the shift by maintaining cGMP
Manage laboratory analysis, stability programmes, review and approval of analytical documentation and reports, laboratory incident
Analytical method development for formulations applying QbD principles, method transfer
Ensuring the quality and compliance of pharmaceutical products through rigorous testing and adherence to established
GMP compliance at PPL sites. Ensure implementation/remediation of the Quality systems, procedures and practices at
Providing Statistical Support to MS&T within the ARPL and GTA for technology transfer of products
