DEVESH MISHRA

Experienced pharmaceutical quality assurance professional with strong background in R&D QA operations, document management, and inspection readiness support for regulatory audits. Lead development of standardized Walkthrough procedures and oversee global database to prevent duplication of solid dose product characteristics. Develop SOPs, job aids, and QA teams training; collaborate with IT to implement tools and processes for QMS approvals.

Collaborative and people-focused project leader who builds effective cross-functional relationships, promotes transparency, and aligns diverse teams toward shared quality and regulatory objectives. Adept at translating complex technical concepts into clear, actionable insights and fostering positive, solutions-driven workplace culture. Skilled in leading cross-functional initiatives and serving as key liaison during regulatory audit preparations.

Project Leader, R&D QA Operations                                                                                                                                            

• Developed global Unique Product Identifier (UPI) database for 500+ solid dose products, eliminating duplication of physical characteristics and reducing cross-contamination risk during packaging.
  • Established standard operating procedures (SOPs), job aids, and forms for approval, ensuring consistent review of product characteristics and eliminating duplication during new product development.
  • Trained R&D QA and Commercial QA teams on UPI determination, improving consistency and accuracy in product identification.
  • Created spreadsheets in coordination with IT, devising process for QMS approvals.
• Reviewed and approved 300+ master documents for manufacturing and packaging of in-process and finished dosage and new product launch, aligning 100% with quality standards and contributing to reducing documentation-related deviations during audits and complying with good documentation practices (GDP).
• Audited and approved 1K+ executed batch records across pilot bioequivalence, submission, stability, and demonstration batches, ensuring 100% regulatory compliance and reducing batch review cycle time while adhering to GDP standards.
• Coordinated review and approval of QMS investigations and SAP F notifications for non-commercial batches, resolving SOP and batch record deviations to ensure GMP compliance, uphold quality standards, and protect product and patient safety.
• Reviewed and approved R&D change control requests and critical documentation, including batch and packaging records, stability protocols, and PDRs, ensuring seamless product transfer from R&D to commercial launch while supporting quality objectives.
  • Oversaw and authorized 60+ R&D change control requests, stability protocols, and PDRs, enhancing documentation accuracy 25% and strengthening regulatory readiness.
• Represented R&D QA in cross-functional meetings, regulatory preparations, and customer inspections, conducting monthly GMP walkthroughs that led to departmental improvements and alignment with commercial and current GMP requirements.

Formulation Development Document Reviewer                                                                                                                          2011 - 2012

• Conducted comprehensive reviews of trial, PE, and PO documents, ensuring proper filing accuracy and retrievability within Document Control Room.
  Developed and implemented first database in Formulation Development to track document status that was later enhanced with embedded formulas and adopted as standard requirement.
• Reviewed stability / submission documents for accuracy and completeness prior to submission to QA for audit.
• Performed routine walkthroughs in FD manufacturing and packaging plant, verifying GMP compliance readiness.

Formulation Technician                                                                                                 2006 - 2011

• Executed pharmaceutical processing techniques, including wet and dry granulation, roller compaction, pellet coating, compression, spray drying, and tablet coating, achieving specified parameters.
• Conducted thorough inspections of stability and submission documents, ensuring accuracy and completeness prior to formal review processes.
• Performed intermediate physical testing on in-process and finished products, maintaining strict adherence to quality control standards.
• Utilized technical expertise to manage complex pharmaceutical manufacturing processes, streamlining workflows and enhancing production efficiency.

Bachelor of Pharmacy (BPharm), Amravati University, India; evaluated as Bachelor of Science (BSc), 

in Pharmacy by York University (Canada)