Kumari B

Key Responsibilities:

Team Size: 8

• Customer Communication & Complaints Management:Handle customer communication and marketing complaints efficiently.
  Investigate and resolve customer complaints to ensure compliance and customer satisfaction.
• Quality Management & Compliance:Oversee preparation and review of Annual Product Quality Reviews (APQR).
  Manage Change Control processes to ensure smooth transitions in quality management.
  Handle deviations and investigate Out-of-Specification (OOS) results to maintain compliance.
  Conduct internal audits and ensure compliance with Good Manufacturing Practices (GMP).
• Validation & Qualification:Prepare and review validation protocols and reports for processes and equipment.
  Coordinate with the maintenance department for equipment qualification protocols and reports.
  Manage qualification of new vendors and evaluate existing vendors for compliance.
• Regulatory Affairs & Documentation:Review completed Batch Production Records (BPRs), analytical worksheets, stability data, and control sample records before API release.
  Review and execute technical agreements received from customers with mutual consent.
  Prepare and review Open Part (Application Part), Closed Part (Restricted Part), and Semi-Finished Product dossiers.
  Respond to customer and regulatory authority queries, ensuring timely and accurate communication.
  Compile Drug Master Files (DMF) including US-DMF, APIMF, and TGA submissions.
  

Key Achievements: Key Responsibilities:

Team Size: 5

• Provided review and support to client sites during regulatory and customer audits, ensuring compliance and successful audit outcomes.
• Regulatory Support & Compliance:Assisted client regulatory teams in submissions and regulatory activities to ensure compliance with global standards.
  Conducted periodic visits to client manufacturing facilities to oversee Quality Management System (QMS) activities.
  Performed gap analysis on QMS processes and submitted reports to the Head of Department.
  
• Audit Readiness & Quality Oversight:Supported regulatory and customer audits, assisting sites in preparation and compliance.
  Reviewed Batch Manufacturing Records (BMRs) and Analytical Test Reports (ATRs) to ensure product quality and regulatory adherence.
  Evaluated Process Validation, Cleaning Validation, and Analytical Method Validation protocols and reports.
  Reviewed investigation reports including OOS (Out-of-Specification), Deviations, APQR reports, Change Controls, Incidents, and Marketing Complaints.
  
• Customer Support & Coordination:Collaborated with marketing departments and manufacturing plants to ensure the timely completion of customer support activities, including customer questionnaires and technical documentation.
  

Key Achievements: Key Responsibilities:

Team Size: 6

• Successfully documented and implemented Good Manufacturing Practices (GMP) to ensure compliance.
• Effectively handled customer audits from IPCA, MANKIND, MoHS, and BAIYU Pharmaceuticals Ltd. (Virtual), ensuring audit readiness and successful outcomes.
• Customer Communication & Complaint Handling:Managed customer communication and addressed marketing complaints efficiently.
  Investigated and resolved customer complaints, ensuring timely corrective and preventive actions.
• Quality Management & Compliance:Led the preparation and review of Annual Product Quality Reviews (APQR).
  Oversaw Change Control Management, ensuring smooth implementation of process modifications.
  Managed deviations and Out-of-Specification (OOS) investigations to maintain quality standards.
  Conducted internal audits to assess compliance with GMP and regulatory requirements.
• Validation & Equipment Qualification:Coordinated with the maintenance department for the preparation and review of equipment qualification protocols and reports.
  Reviewed completed Batch Production Records (BPRs), analytical worksheets, stability data, and control sample records before API release.
  Prepared and reviewed validation protocols and reports, ensuring regulatory compliance.
• Vendor & Technical Documentation Management:Qualified new vendors and evaluated existing vendors for quality compliance.
  Reviewed and executed technical agreements received from customers with mutual consent.
• Regulatory & Technical Expertise:Created and managed Reaction Operating Schemes (ROS) using ChemDraw software, ensuring accurate representation of chemical processes.
  

Team Size: 4

• Successfully documented and implemented GMP at client facilities, ensuring regulatory compliance and operational efficiency.

• Prepared and reviewed Open Part (Application Part), Closed Part (Restricted Part), and Semi-Finished Product dossiers.
• Responded to customer and regulatory authority queries, ensuring timely and accurate communication.
• Compiled Drug Master Files (DMF), including US-DMF, APIMF, and TGA submissions.
• Coordinated with QC, QA, and Production departments for efficient DMF compilation.

• Prepared Annual Product Quality Reviews (APQR) of APIs, including trend analysis and reporting.
• Reviewed Quality Assurance procedures at client sites, identifying and documenting observations for improvement.
• Updated and corrected SOPs and QA procedures based on observations and regulatory requirements.
• Drafted Standard Operating Procedures (SOPs) aligned with client-specific requirements.
• Conducted pre-audit assessments of client facilities to ensure readiness for customer and regulatory audits.
• Provided guidance and assistance in DMF compilation, ensuring regulatory compliance.
• Trained personnel on Internal Audits, Change Control, Deviations, OOS Investigations, and Customer Complaint Handling.
• Assisted in the preparation and review of Annual Product Quality Reviews (APQRs), ensuring accuracy and completeness.

Team Size: 12

• Successfully compiled Drug Master Files (DMF) in eCTD format with PDF bookmarks, ensuring efficient regulatory submissions.

• Prepared and reviewed Open Part (Application Part), Closed Part (Restricted Part), and Semi-Finished Product dossiers.
• Responded to customer and regulatory authority queries, ensuring compliance and timely communication.
• Compiled DMFs including US-DMF, APIMF, and TGA submissions.
• Coordinated with QC, QA, and Production departments for efficient DMF compilation.
• Compiled Drug Master Files (DMF) in eCTD format, ensuring proper structure and compliance with regulatory standards.

• Prepared Annual Product Quality Reviews (APQR) of APIs, including trend analysis and reporting.
• Managed Change Control processes, ensuring smooth transitions and compliance with regulatory guidelines.
• Handled and investigated customer complaints, returned goods, and product recalls.
• Managed deviations and Out-of-Specification (OOS) investigations, ensuring thorough root cause analysis and corrective actions.
• Coordinated with the maintenance department for the preparation and review of equipment qualification protocols and reports.
• Reviewed completed Batch Production Records (BPRs) and analytical records before API release.
• Developed and implemented training schedules, coordinating with relevant departments for execution.
• Prepared and reviewed validation protocols and reports related to process validation and cleaning validation.
• Managed qualification of new vendors and evaluation of existing vendors for compliance.
• Provided support to the Quality Head during customer and regulatory audits, ensuring audit readiness and successful outcomes.

Team Size: 12

• Conducted gap analysis through a thorough review of documents before USFDA and TGA inspections, ensuring compliance and audit readiness.

• Prepared and reviewed Open Part (Application Part) and Closed Part (Restricted Part) dossiers.
• Compiled Drug Master Files (DMF), including US-DMF, APIMF, and TGA submissions.
• Coordinated with QC, QA, and Production departments for efficient DMF compilation.

• Prepared Annual Product Quality Reviews (APQR) of APIs, incorporating trend charts and ensuring compliance with current regulatory requirements.
• Monitored and evaluated Change Controls related to vendor changes, equipment modifications, process updates, SOP revisions, specifications, and testing methods.
• Recorded and investigated deviations and contributed to Out-of-Specification (OOS) investigations.
• Coordinated with the maintenance department for the preparation and review of equipment qualification protocols and reports.
• Reviewed completed Batch Production Records (BPRs), analytical worksheets, stability data, and control sample records before API release.
• Developed training schedules in coordination with relevant departments and ensured effective implementation.
• Prepared the annual internal audit schedule and managed internal audits within the QA department.
• Prepared and reviewed validation protocols and reports related to process validation, ensuring adherence to regulatory requirements.

Team Size: 10

• Streamlined production documentation, ensuring accuracy, compliance, and efficiency in records management.

• Issued controlled copies of Batch Production Records (BPRs), laboratory formats, SOPs, specifications, and testing procedures to relevant departments.
• Initiated and managed Change Controls related to the QA department.
• Recorded and monitored Deviations and Out-of-Specification (OOS) results, ensuring proper investigation and corrective actions.
• Maintained records of customer complaints, returned goods, and rejected materials, ensuring timely resolution.
• Prepared and reviewed process validation protocols and reports to ensure compliance with regulatory standards.
• Monitored packing, labeling, and dispatch activities of finished products to ensure compliance with quality standards.
• Reviewed completed BPRs, analytical worksheets, stability data, and control sample records before API release for distribution.
• Participated in internal audits of QA and provided support during customer and regulatory audits.
• Prepared Annual Product Quality Reviews (APQRs) for APIs, including trend charts and analysis.