Responsibilities: Evaluation of compliance action from audit observation and facilitate compliance in coordination with respective function.Initiate necessary training plans to support compliance actionEvaluate current systems in view of audit deficiency and regulatory expectations.Prepare training materials to train the personnel.Create awareness across the site and drive quality culture.Update with all different country guidelines i.e. MHRA, USFDA, MCC, TGA, ICH etc.Create awareness across the site on regulatory guidelines.To investigate and review the Incidents/Deviation/OOS/OOT of different departments.Review of Quality policies, Quality manual & Site master file.To prepare and review QA SOP’s and to review and approve other department SOP’s.To review TNI & calendar preparation in all different departments across the site.Maintain the training matrix across the site with 100% compliance.Monitor training performance across the site.To perform the Gap/Risk Analysis of different activities across the site.Responsible for review of Master Formula Records/APQR.Responsible for review of BMR, BPR and master formula record and BOM.Responsible for review of BOM of RM.To prepare & submission of dossier for product approval.
Job Title
Training Manager - OSD Manufacturing