Summary
Overview
Work History
Education
Skills
Accomplishments
Disclaimer
Languages
Professional References
Affiliations
Certification
Languages
Timeline
Ram Tupakula

Ram Tupakula

Levittown

Summary

Accomplished Quality Management Systems (QMS) and validation professional with 12 years of experience in pharmaceutical manufacturing regulated by the USFDA, MHRA, ANVISA, TGA, and Health Canada. Skilled in operational excellence, regulatory compliance, and digital transformation, including MES, serialization and aggregation (track and trace), and cloud-based QMS. Experienced in managing deviations, OOS/microbial excursions, and CAPA implementation to ensure product quality and global compliance. Proven track record in validation lifecycle documentation, audit readiness, and driving continuous improvement across manufacturing and quality operations.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Senior Manager- Quality Assurance- Validations

QSOL(Quality Solutions)
01.2024 - 08.2025
  • Led cross-functional teams to implement quality improvement initiatives.
  • Developed and executed strategic plans for operational excellence.
  • Facilitated training sessions to enhance team capabilities and knowledge.
  • Managed vendor relationships to ensure quality compliance and service delivery.
  • Coordinated with stakeholders to align projects with organizational goals.
  • Managed a team of 10+ employees by providing guidance, setting goals and objectives, delegating tasks, and monitoring performance.
  • Developed and implemented strategies to improve operational efficiency, reduce costs, and increase productivity.
  • Mentored junior staff in the organization's business processes, customer service standards, and quality assurance protocols.
  • Facilitated root cause analysis meetings to resolve product quality concerns effectively.
  • Investigated customer complaints related to product quality issues and ensured corrective actions were taken as needed.
  • Collaborated with other departments such as engineering, manufacturing, research and development to resolve product-related issues.
  • Ensured that all relevant documents were reviewed, approved, stored securely and maintained according to good documentation practices.
  • Reviewed vendor qualifications prior to selection including supplier audit results and certificate of analysis.
  • Managed the development of test plans, protocols, specifications, and reports for new products or product changes.
  • Coordinated external audits from customers or regulatory agencies ensuring that all requirements are met prior to audit completion.

Deputy Manager -SME Manufacturing Operations

Medivant Health Care
03.2023 - 12.2023
  • Led cross-functional teams across multiple sites and remote environments, ensuring project objectives were met on schedule, while maintaining compliance with global quality standards.
  • Directed and mentored team members in the execution of commissioning, qualification, and validation (CQV) activities, driving operational efficiency, and adherence to regulatory requirements.
  • Spearheaded CAPA initiatives, leading teams through root cause analysis (RCA) workshops to resolve deviations, minimize recurrence, and strengthen operational controls.
  • Led investigation teams for microbial excursions and out-of-limit (OOL) events, implementing corrective strategies in collaboration with global quality functions.
  • Guided teams in validation lifecycle documentation, overseeing the authoring, reviewing, and approval process through cloud-based QMS systems, ensuring compliance with US FDA, MHRA, TGA, ANVISA, and Health Canada regulations.
  • Fostered a culture of collaboration, accountability, and continuous improvement by leading both onsite and remote teams to achieve business and compliance objectives.

Deputy Manager of Quality Management Systems

Biocon Pharmaceuticals
04.2022 - 02.2023
  • Managed and executed deviation, CAPA, and change control systems, ensuring timely review, approval, and closure of quality records in compliance with US FDA, EU, MHRA, TGA, and Health Canada requirements.
  • Performed and led root cause analysis (RCA) using 5-Why, Fishbone, FMEA, and Fault Tree methodologies, ensuring effective CAPA implementation and reducing the recurrence of deviations, OOS, and OOT events.
  • Reviewed, assessed, and approved change controls, directly evaluating the impact on equipment, manufacturing processes, cleaning validation, and regulatory submissions, while coaching teams on effective change management practices.
  • Conducted and facilitated risk assessments (ICH Q9) for processes, equipment, and quality events, embedding risk outcomes into site risk registers, and driving proactive mitigation strategies.
  • Prepared and managed Periodic Product Quality Reviews (PQRs/APRs).
  • Collaborated with and influenced cross-functional stakeholders (Manufacturing, QC, Engineering, Regulatory Affairs, Supply Chain), ensuring operational compliance and alignment with business priorities.
  • Mentored, trained, and guided quality executives and officers in deviation handling, Good Documentation Practices (GDP), and regulatory compliance, fostering a culture of accountability and quality ownership.
  • Escalated and presented significant quality risks, compliance concerns, and trend analyses to senior management, providing data-driven impact assessments and mitigation strategies for proactive decision-making.

Assistant Manager of Quality Management systems and MES

Biological E. Limited
10.2019 - 04.2022
  • Led and managed a team of 15 QMS professionals and 6 MES specialists, ensuring alignment of Quality Management and MES functions with site and global GMP standards.
  • Directed QMS operations, including manufacturing investigations related to data loss, product testing failures (OOLs), microbial excursions (OOS), change controls, training, and compliance, ensuring timely and compliant resolution.
  • Ensured timely batch release by driving investigation closure, coordinating with QA/QC, and maintaining compliance with regulatory expectations (USFDA, EU, MHRA, TGA, Health Canada).
  • Implemented and validated the HITACHI HITPHAMS Pharmaceutical MES system, embedding ALCOA+ principles into online data entry and electronic batch record (EBR) design.
  • Designed and executed step-by-step batch record workflows covering material requests, dispensing, formulation, in-process checks, packaging, and batch disposition, integrating site practices into MES.
  • Directed system integration of MES with LIMS, ERP (SAP), and QMS systems, ensuring seamless data flow, real-time visibility, and process standardization across departments.
  • Oversaw and performed validation activities (URS, FS, DQ, IQ/OQ/PQ) for MES modules, ensuring compliance with GAMP 5 and 21 CFR Part 11/Annex 11 requirements.
  • Mentored, trained, and coached team members in MES usage, deviation handling, GDP practices, and compliance culture, strengthening digital adoption and data integrity awareness.
  • Collaborated with Manufacturing, QC, Regulatory, IT, and Supply Chain teams to harmonize MES/QMS practices, optimize workflows, and support continuous improvement.
  • Escalated and presented key quality risks, investigation trends, and MES implementation progress to senior management, providing impact assessments and mitigation strategies.

Senior Executive of Injectables Manufacturing Process

Aurobindo Pharma Ltd.
07.2018 - 10.2019
  • Executed the end-to-end manufacturing of lyophilized injectable products, operating lyophilizers, monitoring cycles, and ensuring aseptic processing compliance with GMP standards.
  • Performed equipment setup, operation, and in-process monitoring of lyophilizers, sterile filling lines, and related support systems to maintain consistent product quality.
  • Conducted manufacturing investigations for deviations, microbial excursions, OOS/OOT events, and equipment malfunctions, ensuring thorough documentation and root cause identification.
  • Applied RCA tools (5 Whys, Fishbone, FMEA, Human Error Analysis) to analyze failures, and directly implemented CAPAs to prevent recurrence.
  • Prepared and reviewed batch manufacturing records, logbooks, and supporting documents, ensuring accuracy, GDP compliance, and readiness for timely batch release.
  • Supported validation and qualification activities for lyophilizers, sterile filling equipment, and cleanroom processes during routine and campaign production.
  • Entered real-time manufacturing data into controlled systems, maintaining compliance with ALCOA+ data integrity principles.
  • Assisted cross-functional teams (QA, QC, Engineering) during investigations and CAPA implementation by providing direct manufacturing process insights.
  • Participated in operator training sessions, sharing hands-on knowledge of lyophilization processes, aseptic practices, and deviation handling.

Executive of Manufacturing Compliance

Pfizer Healthcare Pvt. Ltd.
03.2014 - 06.2018
  • Began career as a Manufacturing Executive in sterile dry powder injectables, executing aseptic operations, batch documentation, and adherence to cGMP practices.
  • Transitioned to Training and Compliance for the manufacturing block, developing and delivering GMP/GDP and job-oriented training programs, ensuring workforce readiness, and compliance with internal and regulatory standards.
  • Advanced to the Compliance & Remediation Team as recognition of performance, taking ownership of validation protocols, manufacturing investigations, and change control management.
  • Executed validation and qualification projects, including: NVPC (Non-Viable Particle Count) monitoring system implementation aligned with ISO 14644 recommended sampling plans.
    Autoclave load qualification for both product-contact and non-contact parts.
    Qualification of vial washing machines, depyrogenation tunnels, vial filling and stoppering equipment, LAFs, and cleanroom HVAC systems.
    Aseptic process simulations (media fills) and hold-time studies for sterile components and intermediates.
  • Conducted root cause investigations for manufacturing deviations and OOS/OOT events, preparing detailed reports, and implementing CAPAs to strengthen process reliability.
  • Reviewed and executed change controls to evaluate the impact of equipment, process, and facility modifications, ensuring alignment with QMS and regulatory requirements.
  • Serialization and aggregation (track and trace) project implementation, ensuring system readiness for DSCSA/EU FMD compliance, integrating packaging lines with serialization systems, and enabling unit-level and bundle-level traceability to strengthen supply chain integrity.
  • Collaborated with QA, QC, Engineering, and Manufacturing teams during remediation projects, ensuring timely completion of corrective actions, and supporting inspection readiness.

Education

Master of Science - Computer Information Systems Specialization in AI

Indiana Wesleyan University, Merrillville
06-2027

MASTER OF PHARMACY - Pharmaceutical Operations

Jawaharlal Nehru Technological University, Kakinada
11.2013
GPA: 85%

BACHELOR OF PHARMACY -

Jawaharlal Nehru technological University, Kakinada
04.2011
GPA: First Class Marks

DIPLOMA IN PHARMACY

State Board of Technical Education And Training, Guntur
04.2007

Skills

  • Quality management
  • Machine learning
  • Quality assurance
  • Team management
  • Project management
  • Regulatory compliance
  • Root cause analysis
  • Cross-functional collaboration
  • Verbal and written communication

Accomplishments

  • PGS Cost-Saving Award: Recognized for Leading Cost-Saving Initiatives
  • PGS Mission Award: Awarded for Designing and Implementing Comprehensive On-The-Job Training Programs
  • BIOLOGICAL E STAR AWARD: Honored for Sustained Excellence, Consistently Exceeding Performance Expectations in Quality Management systems
  • BIOLOGICAL E STAR AWARD – SME for USFDA audit: recognized for serving as a subject matter expert (SME) for root cause analysis and CAPA implementation plan critical deviations, leading to zero observations during USFDA auditing

Disclaimer

I hereby certify that the information given by me in the documents true and to the best of my knowledge.

Languages

  • English
  • Hindi
  • Telugu

Professional References

  • Sreenivasulu Chitti, Director- Quality and compliance, MERCK & CO., INC, +91 8008234016
  • Kayapati Muralidhar, General Manager- Manufacturing, BIOLOGICAL E. PHARMA, +91 9600014554

Affiliations

  • PGS Cost-Saving Award – Recognized for leading cost optimization initiatives that reduced operational expenses while maintaining compliance.
  • PGS Mission Award – Honored for designing and implementing comprehensive on-the-job training programs, improving workforce capability.
  • Biological E STAR Award – Awarded for sustained excellence in Quality Management Systems, consistently exceeding performance expectations.
  • Biological E STAR Award – SME for USFDA Audit – Recognized as Subject Matter Expert (SME) for root cause analysis and CAPA implementation during critical deviation investigations, contributing to a zero-observation USFDA audit outcome.
  • Audit SME Roles – Actively served as SME during USFDA, MHRA, TGA, and ANVISA inspections, ensuring seamless audit readiness and regulatory alignment.
  • Community Engagement – Conducted internal training sessions on GMP/GDP compliance, RCA/CAPA best practices, and data integrity, strengthening a culture of quality across teams.

Certification

  • Six Sigma Green Belt Certification – Pfizer, 2018

Languages

English
Full Professional
Telugu
Native/ Bilingual
Hindi
Professional

Timeline

Senior Manager- Quality Assurance- Validations - QSOL(Quality Solutions)
01.2024 - 08.2025
Deputy Manager -SME Manufacturing Operations - Medivant Health Care
03.2023 - 12.2023
Deputy Manager of Quality Management Systems - Biocon Pharmaceuticals
04.2022 - 02.2023
Assistant Manager of Quality Management systems and MES - Biological E. Limited
10.2019 - 04.2022
Senior Executive of Injectables Manufacturing Process - Aurobindo Pharma Ltd.
07.2018 - 10.2019
Executive of Manufacturing Compliance - Pfizer Healthcare Pvt. Ltd.
03.2014 - 06.2018
Indiana Wesleyan University - Master of Science, Computer Information Systems Specialization in AI
Jawaharlal Nehru Technological University - MASTER OF PHARMACY, Pharmaceutical Operations
Jawaharlal Nehru technological University - BACHELOR OF PHARMACY,
State Board of Technical Education And Training - , DIPLOMA IN PHARMACY

Similar Profiles

CREATE PROFILE