KRISHNA CHAITANYA YELLAPANTHULU
Manager QA Audits and Compliance
Visakhapatnam
Summary
Detail-driven Compliance personnel focused on maximizing company compliance with applicable laws and standards. Knowledgeable about internal controls, process evaluations and procedural reviews. Self-assured individual trained to be focused Compliance Specialist bringing more than 12 years working.
Proficient in Quality Assurance and Compliance in an auditing capacity, Data governance, Inspection readiness and Supplier quality. Successfully implemented data integrity plan and sustained inspection readiness program at site coordinating with site management and global SMEs. Accomplished site goal to achieve the OAI status from VAI status through a structured inspection readiness plan. Well experienced in facing Regulatory inspections and management of pre and post inspection activities. Expertise in writing audit reports and responses for regulatory audits through identification of appropriate CAPA and effectiveness check plan. Performed gap assessments for regulatory guidelines (USFDA, EU Annex-1 and Health Canada), identified mitigating actions and implemented the same. Have good knowledge of manufacturing operations including both Biologics and Pharmaceutical facilities.
Overview
13
13
years of professional experience
5
5
years of post-secondary education
Work History
Data Integrity Manager
Pfizer Health Care India Private Limited
10.2022 - Current
- Developed and implemented Data Integrity plan to ensure data governance and compliance across all GMP activities
- Written audit responses for 5 regulatory and 10 corporate audits and ensured effective CAPAs were identified and implemented
- Ensured the status of implementation is effectively communicated to site management through inspection readiness program
- Trained 2400+ colleagues on Data integrity requirements (ALCOA principles) and conducted various workshops, cultural events to enhance Quality and Integrity culture
- Performed data integrity investigations and ensured actions are derived to mitigate the problem.
- Accomplished multiple tasks within established timeframes.
- Facilitated successful cross-functional collaborations for the completion of key projects, fostering strong working relationships among team members.
- Established robust risk mitigation strategies to safeguard against potential operational challenges or disruptions.
Associate Manager, QA Audits and Compliance
Pfizer Health Care India Private Limited
06.2016 - 10.2022
- Part of site QA audits and compliance team responsible for internal audits and compliance
- Certified Lead auditor per Pfizer corporate policy and prepared annual internal audit schedules, audit plans and performed internal audits to verify GMP and GLP compliance
- Participated in supplier audits and verified compliance against Quality agreements and applicable regulations
- Performed gap assessments for regulatory guidance (Eudralex, 21 CFR Parts 210, 211) and have good understanding of ICH, PICS and PDA guidance.
- Proposed and approved CAPAs and effectiveness checks
- Implemented supplier management system (SMS) for supplier management activities.
- Compiled metrics and prepared presentations for Site Quality Review Team (S-QRT) on monthly and quarterly basis
Executive, Manufacturing Quality Assurance
Pfizer Health Care India Private Limited
03.2015 - 06.2016
- Responsible for manufacturing quality activities related to Formulation, Filling and capping, Terminal sterilization, Visual inspection and Packaging operations
- Performed line clearance, start-up checks and in process sampling activities
- Conducted root cause analysis for recurring issues, leading to implementation of effective preventative measures that reduced defects.
- Served as subject matter expert for Quality Assurance-related topics during internal and external presentations.
- Conducted risk assessments to identify and mitigate potential quality issues.
Officer, In process Quality Assurance
Indian Immunologicals Limited
09.2011 - 03.2015
- Part of in-process quality assurance team responsible for monitoring and ensuring adherence to cGMP in bio-process bulk preparation and formulation & filling of Vaccines
- Responsible for execution of aseptic media fill simulation studies, preparation of protocols and reports for process validation studies
- Prepared annual product quality review reports with trend analysis.
- Prepared, reviewed and approved batch records and standard operating procedures
- Conducted regular reviews of operations and identified areas for improvement.
Education
Master of Science - Biotechnology
GITAM University
Visakhapatnam, India 06.2009 - 06.2011
Bachelor of Science - Biotechnology
Andhra University
Visakhapatnam, India 06.2006 - 05.2009
Skills
Attention to Detail
undefinedProfessional Overview
Quality Assurance Compliance Manager with experience in Quality Compliance and Auditing roles. Successfully ensured cGMP compliance through actionable insights and execution of change/innovation agenda. Diverse set of skill sets obtained through exposure to different areas of biopharmaceutical operations.
Timeline
Data Integrity Manager
Pfizer Health Care India Private Limited
10.2022 - Current
Associate Manager, QA Audits and Compliance
Pfizer Health Care India Private Limited
06.2016 - 10.2022
Executive, Manufacturing Quality Assurance
Pfizer Health Care India Private Limited
03.2015 - 06.2016
Officer, In process Quality Assurance
Indian Immunologicals Limited
09.2011 - 03.2015
Master of Science - Biotechnology
GITAM University
06.2009 - 06.2011
Bachelor of Science - Biotechnology
Andhra University
06.2006 - 05.2009
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