+91 - 8297150003
B Ravi Shankar
[email protected]
PROFILE SUMMARY
Cultivated a comprehensive skill set across various roles in the pharmaceutical industry, such as analytical expert and
project lead, significantly improving expertise in product lifecycle management and quality control and quality assurance
practices.
Audit Preparation & Response: Being part of the audit preparedness and response team, providing comprehensive responses
to technical questions related to development, Quality Control (QC), and Drug Quality Assurance (DQA) functions during
regulatory audits.
Direct the AR&D, DQA and Clinical Development, departments at Cohance Life Sciences, managing essential functions and
guaranteeing strict adherence to regulatory standards.
Holds extensive expertise in analytical methodologies and quality management systems, safeguarding the integrity and
reliability of data throughout the entire product development lifecycle.
Expert in handling market complaints, deviations, OOS, OOT during product life cycle management.
Author and reviewer of CMC modules, Annual reports, and other quality documents.
CAPA Implementation: Taking responsibility for providing and implementing Corrective and Preventive Actions (CAPA) for
observations made or identified during internal audits, ensuring compliance and addressing any issues effectively.
Led the effective execution of numerous bioequivalence studies, playing a crucial role in the development of innovative drug
formulations by supporting formulation teams with the development of discriminatory dissolution methods..
Highly skilled in using instruments like HPLC, LCMS, GC, ICPMS and Dissolution.
Exhibited strong leadership skills by nurturing team development and promoting collaboration, which propelled operational
excellence and facilitated the achievement of strategic objectives within the organization.
Realized a significant decrease in project turnaround time by introducing streamlined processes and improving communication
among cross-functional teams, which led to enhanced efficiency and productivity.
Specialize in the establishment and validation of analytical methods for intricate drug formulations, guaranteeing adherence
to industry standards and regulatory requirements.
Expertise in advanced chromatographic techniques and quality management systems ensures the delivery of high-quality
products that meet stringent industry standards.
CORE COMPETENCIES
Strategic Planning & Leadership Analytical Expertise Pharmaceutical Product Management
Research & Development Clinical Study Design Regulatory Affairs and Compliance
System & Quality Assurance Budgeting and Forecasting Cross- functional Coordination
SOFT SKILLS EDUCATION
Communication & Collaboration M.Sc. (Organic Chemistry) from Andhra University, 2004
B.Sc. (Mathematics physics chemistry) from Andhra
Leadership & Delegation University, 2002
Certified Quality Auditor (CQA)
Planning & Innovation Good Manufacturing Practices (GMP) Certification
Visionary & Decision-maker
ACHIVEMENTS
Analytical Expertise Recognized for planning, development, and execution of In-
vitro binding studies.
Problem- solving Awarded with “Young Promising Executive 2008” From
Sandoz, Mumbai
Received “Chairman’s Excellence at Work Award” From Dr.
Reddy’s, Hyderabad
WORK EXPERIENCE
Head of the Department (Formulation – Clinical Development, DQA, and ARD) Cohance Life Sciences: Jun’16 – Present
Key Result Areas:
Method Development & Validation: Providing support for method development and validation, including the review,
approval, and authorization of related documents, ensuring robust and reliable analytical methods.
Formulation Development: Supporting formulation development by planning analyses and performing reverse engineering
for excipients in Reference Listed Drugs (RLDs), facilitating product innovation and development. Also in the development of
discriminatory dissolution development.
Designing & Executing Studies: Provides support in designing and executing Bioequivalence (BE) studies, coordinating with
external Contract Research Organizations (CROs) in compliance with regulatory guidance to ensure accurate and reliable
results.
Managing Quality: Leading the DQA department to ensure adherence to cGMP (Current Good Manufacturing Practices), GLP
(Good Laboratory Practices), QA agreements, and regulatory requirements. Maintaining high-quality standards and ensuring
operational compliance with standard operating procedures.
Budget Management: Being accountable for preparing and forecasting budgets, meeting targeted financial goals for the ARD
function, and managing financial resources effectively.
Reviewing Quality Modules: Reviewing and preparing drug substance Drug Master File (DMF) Quality modules, ensuring
comprehensive and accurate documentation for regulatory submissions.
Complex Drug Substances: Managing complex drug substances, demonstrating API equivalency where required, and ensuring
compliance with regulatory standards.
Specifications & MOA: Preparing, reviewing, and approving specifications and Modes of Action (MOA) for APIs and finished
formulations, ensuring quality and consistency in product development.
Project Management: Steering the successful rollout of projects, defining scope, setting timelines, analyzing requirements,
prioritizing tasks, identifying dependencies, and evaluating risks while adhering to pre-set budgets.
Reviewing SOPs & Specifications: Reviewing, approving, and authorizing Standard Operating Procedures (SOPs) related to
analytical method development, as well as specifications and methods of analysis.
Regulatory Submissions: Reviewing, approving, and authorizing analytical sections of regulatory submissions, including
specifications justifications and method validations. Supporting the regulatory team with data analysis and responses to
regulatory queries or deficiencies.
Development Costs & Reporting: Managing and reporting on development costs, capacity, resources, projects, and
requirements to senior management, ensuring effective allocation and use of resources.
Investigations & Quality Procedures: Leading investigations for Market complaints, Out-of-Specification (OOS) and Out-of-
Trend (OOT) results, ensuring adherence to quality procedures and timely resolution of deviations and change controls.
Senior Analytical Scientist (Analytical Expert) Novartis Pharma, Hyderabad: Apr’13 – Jun’16
Key Result Areas:
Analytical Expertise: Demonstrated advanced expertise in the analytical development of parental and topical formulations,
contributing significantly to the accuracy and reliability of complex drug products.
Batch Release & Stability Studies: Successfully managed early phase drug substance batch releases and conducted thorough
stability studies, ensuring product quality and regulatory compliance.
Project Management: Efficiently handled comprehensive projects within the analytical development function, overseeing all
aspects from initial planning to final execution.
Deviation Investigation: Acted as the Lead Investigator for various deviations, utilizing Track Wise software to address and
resolve issues effectively, enhancing project integrity and compliance.
Global Coordination: Coordinated with the Global Analytical Project Leader for timely escalations and status reviews, ensuring
seamless project progress and stakeholder communication.
External Collaboration: Managed collaborations with external laboratories to study extractable and leachable compounds for
parental formulations, ensuring comprehensive safety evaluations.
Batch Records Approval: Reviewed and approved analytical batch records in alignment with Standard Operating Procedures
(SOPs), maintaining high standards of documentation and process adherence.
Equipment Qualification: Responsible for the initial qualification of analytical equipment and approval of qualification
documents, ensuring reliable and accurate equipment performance.
Regulatory Compliance: Proposed storage conditions, retest data, and specifications, and made batch release decisions in
accordance with Novartis requirements, ensuring regulatory adherence and product quality.
Assistant Manager (Group Lead – External Sites QA/QC Management) GlaxoSmithKline Pharma: Apr’11 – Apr’13
Key Result Areas:
Cross-Functional Interface: Effectively interfaced with FR&D, AR&D, and QA/QC teams to strategically plan and focus on
project deliverables, ensuring alignment across departments and smooth project execution.
Change Control & QC Approval: Reviewed and approved project change controls and QC release of drug products and
substances, facilitating market entry while maintaining high standards of quality and compliance.
Project Reviews & Roadblock Management: Conducted periodic project reviews and facilitated roadblock discussions to
address issues and ensure adherence to project timelines.
Method Establishment & Transfer: Successfully established and transferred robust analytical methods to Third Party
Organizations (TPOs) and internal sites, ensuring consistency and reliability across production environments.
Analytical Development Support: Supported, reviewed, and verified analytical development studies for new product
launches, ensuring studies were accurate, complete, and aligned with product specifications.
Tech Transfer Documentation: Reviewed and approved Development Batch Manufacturing Records to ensure smooth
technology transfer and integration into production processes.
Data Interpretation: Expertly interpreted data related to chromatography, spectroscopy, and physical testing for global
product development projects, providing critical insights for product quality and development.
CMC Assessment: Assessed Chemistry, Manufacturing, and Controls (CMC) sections of projects to ensure timely submission
to health authorities, facilitating regulatory approvals and compliance.
Incident Investigation & CAPA Implementation: Investigated incidents and Out-of-Specification (OOS) results,
implementing corrective and preventive actions (CAPAs) to address and resolve issues effectively.
Change Control Management: Oversaw change control management functions across the department, ensuring proper
documentation, review, and implementation of changes to maintain project and product integrity.
Regulatory Query Resolution: Resolved queries and regulatory deficiencies related to analytical methods, ensuring
compliance with regulatory standards and improving documentation processes.
Senior Analytical Scientist Sandoz, Mumbai: Oct’07 – Mar’11
Junior Manager – Analytical Development Dr. Reddy’s Labs, Hyderabad: Aug’04 – Oct’07
PERSONAL DETAILS
Date of Birth: 28th April 1982 | Languages Known: English, Telugu and Hindi
Address: Flat No: 623; Kanakadhara Landmark apartments; Kapra; Hyderabad; Telangana
