Anna Pundlik Bhombe
Corporate Quality Assurance
Chhatrapati Sambhaji Nagar,Maharashtra
Summary
Dynamic team leader with extensive experience in vendor qualification and lifecycle quality management across APIs, KSMs, intermediates, and raw materials. Managed a team of five while reporting directly to the VP of Corporate QA, conducting over 150 plus domestic and international audits. Demonstrated expertise in strategic supplier selection, contract compliance monitoring, and risk-based requalification, all aimed at enhancing supply chain reliability and ensuring regulatory readiness. Committed to fostering a culture of quality and continuous improvement within the organization. Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Deputy Manager-Corporate Quality Assurance
Harman Finochem Limited
07.2021 - Current
- Led Audit Management processes (internal & external) for APIs, excipients, and packing materials, ensuring end-to-end compliance with cGMP and regulatory standards.
- Planned, scheduled, and executed audits, including internal, supplier, and customer audits, to proactively identify and mitigate quality risks.
- Performed comprehensive audits of API, excipient, and packaging suppliers, preparing detailed audit reports with actionable recommendations.
- Monitored compliance status and ensured timely closure of audit findings through effective CAPA implementation.
- Developed and reviewed audit responses for customer and regulatory inspections, achieving high compliance ratings and successful audit outcomes.
Assistant Manager-Compliance
Glenmark Pharmaceuticals Limited
01.2019 - 04.2021
- Led Laboratory Compliance initiatives, driving OOS investigations, change controls, deviations, and incident management to ensure timely closure and regulatory compliance.
- Directed market complaint resolution and performed data-driven trending of QMS elements, enhancing risk prediction and prevention.
- Conducted comprehensive gap assessments, implementing effective CAPAs to mitigate compliance risks and align with global quality standards.
- Redesigned and streamlined SOPs, reducing process deviations and improving operational efficiency across quality systems.
- Championed a culture of continuous improvement, mentoring cross-functional teams to elevate quality performance and regulatory adherence.
Executive-Quality Assurance
Wockhardt Limited
09.2015 - 01.2019
- Directed vendor management for APIs, Key Starting Materials (KSMs), intermediates, packaging materials, contract testing laboratories, and external service providers to ensure compliance with cGMP and regulatory requirements.
- Planned, executed, and led vendor audits, ensuring thorough assessment of quality systems and operational compliance.
- Monitored periodic qualification and requalification of manufacturers and suppliers to maintain approved vendor status.
- Collaborated with cross-functional teams to strengthen supplier relationships, mitigate supply chain risks, and ensure consistent product quality.
Sr. Officer-Quality Assurance
Ajanta Pharma Limited
07.2011 - 08.2015
- Led end-to-end Quality Management functions, ensuring seamless oversight of critical quality processes.
- Managed change control, deviations, OOS/OOT investigations, and CAPA implementation to maintain compliance with regulatory standards.
- Directed market complaint handling and APQR (Annual Product Quality Review) to ensure product quality and regulatory adherence.
- Performed quarterly trending of QMS elements, identifying potential risks and driving proactive improvements.
- Enhanced compliance and streamlined quality processes, fostering a culture of continuous improvement aligned with global standards.
Officer-Quality Control
Glenmark Pharmaceuticals Limited
01.2011 - 07.2011
- Performed quality control sampling and analysis of raw materials and packing materials to ensure compliance with established specifications.
- Ensured adherence to regulatory standards, maintaining high levels of product integrity and consistency.
- Collaborated with cross-functional teams to address quality-related observations and implement corrective measures.
- Maintained accurate documentation and records, supporting audit readiness and regulatory inspections.
Management Staff
Cipla Limited
11.2009 - 01.2011
- "Quality Control expertise in sampling and analysis of raw materials and packing materials, ensuring compliance with regulatory standards and adherence to established quality specifications."
Education
M.Sc. - Organic Chemistry
Dr. Babasaheb Ambedkar Marathwada University
Chhatrapati Sambhaji Nagar10.2009
B.Sc. - Chemistry, Computer Science
Dr. Babasaheb Ambedkar Marathwada University
Chhatrapati Sambhaji Nagar06.2006
Skills
Accomplished Quality Assurance professional with extensive experience in Vendor management, supplier qualification, and global compliance across pharmaceutical manufacturing Proven expertise in Leading cross-functional teams, conducting 150 domestic and international audits, and managing the Onboarding, qualification, and requalification of vendors for APIs, KSMs, Intermediates, Raw Materials, and Packaging Materials Skilled in Risk assessment, change control, and Quality Technical Agreements (QTA) to ensure robust supply chain compliance
Demonstrated proficiency in Quality Management Systems (QMS) including OOS, deviations, CAPA, market complaints, and incidence management, along with strong knowledge of Computer System Validation (CSV) and GxP requirements Experienced in developing and implementing Global CAPA procedures, maintaining Quality Health Index, and ensuring effective vendor performance monitoring
Certified trainer with a track record of building high-performing teams, driving Continuous improvement initiatives, and fostering compliance culture through Audit planning, data integrity reviews, and documentation excellence Adept at collaborating with senior leadership to align supplier quality strategies with corporate objectives
Certification
ISO 9001:2015 Certified Lead Auditor
Language Proficiency
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Timeline
Deputy Manager-Corporate Quality Assurance
Harman Finochem Limited
07.2021 - Current
Assistant Manager-Compliance
Glenmark Pharmaceuticals Limited
01.2019 - 04.2021
Executive-Quality Assurance
Wockhardt Limited
09.2015 - 01.2019
Sr. Officer-Quality Assurance
Ajanta Pharma Limited
07.2011 - 08.2015
Officer-Quality Control
Glenmark Pharmaceuticals Limited
01.2011 - 07.2011
Management Staff
Cipla Limited
11.2009 - 01.2011
M.Sc. - Organic Chemistry
Dr. Babasaheb Ambedkar Marathwada University
B.Sc. - Chemistry, Computer Science
Dr. Babasaheb Ambedkar Marathwada University
Hobbies and Interests
Reading Books, Photography, Listening music, Long Drive
Training
- Workshop on Computer System Validation and Data Integrity.
- Workshop on Risk Management and control strategy.
- N-Nitrosamine's impurities
- Train the Trainer
- Auditor Certification
- Vendor Development
- Quality Risk Management
Technical Skills
Key Role and current assignments:
Leading a team of vendor management, direct reporting of 5 persons and I am reporting to Vice President-Corporate Quality Assurance.
- Performed 150+ domestic and overseas vendor audits and onboarding process.
- Handling, monitoring and execution of vendor audits of API, KSM, Intermediates, Raw Materials and Packing materials.
- Handling monitoring and execution of Contract Testing Laboratories, External Services etc.
- Selection and identification of strategic supplier from domestic and overseas for API, KSM, Intermediates, Raw Materials and Packing materials.
- Planning for due diligence audit of API, KSM, Intermediates, Raw Materials and Packing materials, contract testing laboratories, external services.
- Issuance of Vendor Evaluation Questionnaire (VEQ), and collection of vendor qualification (VQ) package.
- Review of vendor evaluation questionnaire and VQ package.
- Planning/scheduling of onsite audit of API, KSM, Intermediates, Raw Materials and Packing materials, contract testing laboratories, external services.
- Performing onsite audit, issuance of observation, monitoring compliance and periodic verification of VQ package.
- Periodic Requalification of vendor as and when required.
- Preparation of Quality Technical Agreement (QTA) with vendor and revision of agreement as and when required.
- Preparation and timely updating of Approved vendor list and issuance to respective sites/department for end user requirement.
- Periodic verification of vendor followed by verification of Quality Score (Q-Score).
- Change control Management for listing/desilting of vendor and Performance of risk assessment of Delisting/discontinuation of vendor.
- Internal auditor for all manufacturing sites, periodic audits planning execution and closure. Maintaining Quality Health Index of all sites as a part of Management Review Meeting (MRM).
- Monitoring of Global CAPA procedure and effective implementation across all manufacturing sites.
Other Technical Competencies/Past Assignments and experiance/Current shared responsibilities:
- Hands of experience of Quality Management System Tools (out of Specification, Deviation, Corrective and Preventive Action, Market Complaint, Incidence Management, Change Control).
- Actively involved in software qualification as per Computer System Validation Requirement (Vendor Assessment, GxP assessment, Risk Assessment, Complete qualification, VSR, RTM).
- Documentation (Preparation/Review/Approval of SOP's/Protocols/Reports/Trending of all QMS elements, CAPA based on QMS elements)
- Laboratory Compliance (Out of Calibration, OOS, Incidence, Deviation, Market Complaint etc.)
- Review of Annual Performance Qualification Report (APQR), compilation of data.
- Review Analytical Method Validation summary reports of In house and Contract Testing Laboratories.
- Review of Equipment/Instrument Qualification documents.
- Act as a Trainer and as a part of Train the trainer program and certified trainer for the Vendor Qualification, QMS, Equipment Qualification.
- Review of area qualification documents, temperature mapping.
- Review of validation and qualification documents (Process validation, Cleaning Validation, Analytical method Validation, Equipment Qualification).
- Review/Periodic review of audit trail of electronic systems (Chromatography, LIMS, QAMS, Training Management Module etc.)
- Periodic review of trends of OOS, Incidence, Deviation, Market Complaint and its CAPA's.
signature
"Committed to driving quality excellence, regulatory compliance, and continuous improvement to support organizational growth and customer satisfaction."
Anna Bhombe | Corporate Quality Assurance & Compliance Lead | Bhombe.sunil@gmail.com | +91-9766803274 |
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