ABHISHEK B THITE

• Lead IPQA operations in API manufacturing to ensure compliance with cGMP, ICH, and Company SOPs.
• Monitor and verify in-process activities such as sampling, line clearance, Critical process monitoring , and real time BMR review during production and packaging.
• Supervise IPQA team members and coordinate with production, QC, and Engineering dept. to resolve quality issues efficiently.
• Review and Approve batch production and quality records in real time.
• Review and approve Validation protocols, Qualification documents to support to Validation team.
• Manage and monitor the dispatch related activities in coordination with stores and planning team.
• Handle deviations, change controls, and CAPAS related to in-process operations. Effectiveness checking of CAPAs.
• Conduct training sessions for shop-floor personnel on quality systems and GMP practices.
• Review of APQR.
• Approve and Release of Batch packaging records as per customer requirement and inline with Regulatory authorities.
• Responsible to check compliance at Cipla site based on other companies received observations as per FDA 483 form.
• Support and faced internal and external audits like USFDA, PMDA, ANVISA by ensuring audit readiness.

Key achievements:

• Successfully led the the IPQA team during Regulatory audits like USFDA, PMDA and ANVISA resulting in zero major observations.
• Reduced in-process documentation errors through improved review by changing review mechanism and with training.

• Executed IPQA activities in API manufacturing, ensuring compliance with cGMP, ICH, and regulatory standards.
• Performed in-process checks, line clearances, Process and Cleaning validation sampling activities during manufacturing.
• Supported validation activities including process validation, cleaning validation, and equipment qualification.
• Reviewed Master and executed Batch Manufacturing Records.
• Prepared and reviewed validation protocols and reports in coordination with cross-functional teams.
• Compiled and reviewed Annual Product Quality Reviews (APQR), ensuring completeness, accuracy, and timely submission.
• Performed Export consignment checking activities as per customer and regulatory requirements.
• Acted as Training Coordinator, maintaining training records, planning training calendars, and conducting GMP training sessions for new and existing staff.
• Issuance and Implementation of SOPS and Formats at site level.
• Participated in deviation handling, CAPA implementation, and change control management.
• Supported regulatory audits like USFDA, WHO and internal quality system audits.