3 Audit Observation Jobs

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4.0 - 8.0 years

5 - 11 Lacs

ahmedabad

Work from Office

Summary Job Functions: Audit and Compliance, Quality Technical Agreement, Gap Assessment, Extended CAPA Key Responsibilities: - Drive the self-inspection program at Intas-Biopharma site. Ensure the self-inspection program run as per defined schedule. - Perform risk assessment to determine the frequency of the self- inspection. Ensuring the appropriate CAPAs are identified and implemented in appropriately. - Management of external quality audits. Responsible to facilitate for the management of backroom, coordinate the auditors request, works as scribe during audit, preparation of response etc 4. Tracking and follow up of internal and external audit CAPA. - Verification of CAPA effectiveness o...

Posted 1 month ago

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6.0 - 10.0 years

0 Lacs

andhra pradesh

On-site

Role Overview: You will play a crucial role in leading downstream manufacturing compliance and ensuring quality management systems in line with cGMP and regulatory requirements at a sterile pharmaceutical manufacturing unit. Your contribution will directly impact patients by maintaining the excellence of every product delivered by the company. Your responsibilities will include handling change control management, coordinating with investigators for CAPA identification, reviewing and approving manufacturing records, ensuring compliance to audit observations, monitoring training metrics, and supporting site inspection readiness programs. Key Responsibilities: - Lead downstream manufacturing co...

Posted 2 months ago

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4.0 - 8.0 years

0 Lacs

karnataka

On-site

You will be responsible for reviewing and analyzing alerts triggered in SAS according to the AML SOP within the specified TATs. Cases that require escalation to the Investigation Team must be identified and actioned promptly as per the AML SOP guidelines. Your role will involve assisting the Manager AML by providing comprehensive quality analysis for the reviewed cases. It is essential to effectively communicate any key Financial Crimes risks discovered during the review and analysis of customer accounts to the Line Manager and/or Head of Transactions Monitoring/delegate. Additionally, sharing innovative ideas for enhancing work effectiveness and efficiency will be encouraged. Your responsib...

Posted 3 months ago

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