KRISHNA MOGULLA

16 years of plant QA and corporate QA experience

Quality Assurance and Operational Excellence Professional 15+ years of experience in specialty chemicals or pharmaceutical industry.

Life Sciences Industry Principal |Quality Assurance Specialist | Global Supply Base Quality Manager | IPQA Documentation Compliance Specialist

Core Competencies

In-Process Quality Assurance, GxP Documentation Compliance, GMP Product Release, Batch Approval.

Expiry Date Extension, Release of Master Record, Manufacturing and Packaging Operations, Validations.

Supplier Quality Evaluation Audit, Customer Quality, Continuous Quality Improvement, Specification Setup.

Material Stock Inventory Control, Lean, Six Sigma, Computer System Validations, SAP S4 HANA Implementation.

Professional Synopsis, Expertise

▪  Led high-quality presales and solution evaluations, experience in understanding customer needs and delivering solutions 

▪  Developed and maintained relationships with customers, ensured compliance with SOPs, regulatory requirements, quality best practices

▪  Provided GMP and QA expertise, supporting project activities, approving deviations, change controls, raw materials, and documents.

▪  Adhered to cGMP and supported temperature excursion cases.

▪  Improved quality procedures and processes through TQM, MRP, and S&OP, leading to increased customer satisfaction business success.

▪  Led product and asset projects to ensure returns, strategy consistency, Quality EH&S and Ethics compliance with company standards.

▪  Managed manufacturing areas to prevent complaints, reduce waste, improve efficiency, ensure compliance with cGMP, GMP, BMR, BPR.

▪  Led and developed IPQA staff, trained them to support plant operations, identified and responded to product quality issues promptly.

Experience

Industry Principal Life Sciences                  ITRadiant                                Aug 2022 - Feb 2023

•  Managed ongoing relationships with 2 customers to stay relevant to healthcare technologies vendors.

•  Conducted training sessions on GxP practices for life sciences project teams and collaborated with 2 offices across the globe.

Quality Assurance Manager                      Novartis                                  Mar 2021 - Dec 2021

•  Reviewed and assessed 20% of global clinical supply, site temperature excursion for medication, and provided decision.

•  Checked master batch record as per SOP, expiry date extension, and completed 100% of the review checklist form.

•  Reconciled 100% of records archives in the IT system compliance with GxP documents.

•  Reviewed the batch master packaging records, reviewed temperature excursion cases 180 per year.

Quality Assurance Manager                      Ashland                                   Mar 2009 - Dec 2020

•  Exceeded expectations with 11+ years of experience in 5 roles and 3 promotions.

•  Manufactured 3 types of products (manufacturing, toll, and purchase for resale (PFR)) in corporate quality assurance.

•  Increased product release flow by 18% by reducing time, allocation, and post-goods issues.

•  Decreased slow-moving inventory by 8% per year, saving disposal cost.

•  Managed 25% of products (850 in a year) customer quality questionnaires, spec reviews, agreements, complaints, and returns.

•  Provided quality input with 50% weight on purchasing decisions in supplier selection, improving overall performance.

•  Executed supplier audits, evaluated risk assessment, verified questionnaires, specifications, and agreements.

•  Reorganized after merger acquisitions of $3.2 billion and $690 million, implemented ERP global project in 3 months.

•  Streamlined processes, saving $1.5 million in 10 months by Lean and Six Sigma projects.

•  Supervised product releases in 8 global warehouses in Asia Pacific and EMEA regions.

•  Minimized 28% slow-moving inventory by material movement, shelf-life extension, downgrading, and product risk management.

•  Facilitated EMEA customer support (40% of global requests), completed 85%, remaining dealt with plant QA, tracked time.

•  Acted as a backup for 9 plant QA managers, collaborated with 5 internal department stakeholders, and external customers.

•  Held accountable for product releases in 6 EMEA regional warehouses for inbound goods receipt and outbound deliveries.

•  Reduced inventory by 18% in 2 years with help of planning, sales, and customer support teams.

•  Handled 60 supplier specification changes per year as per organization requirements.

Quality Assurance Chemist                        NATCO Pharma                       Sep 2005 - Feb 2009

•  Ensured quality compliance in 4 manufacturing and packaging areas.

•  Reviewed BPRs, Analytical Results COA, released batches, compiled 10 Annual Product Reports per year summarizing KPIs.

•  Inspected 12 products process validation in 24 months and assured consistent quality.

•  Authored/Revised SOP, Master BPRs, and conducted 4 internal audits in 2 years to ensure compliance status.

•  Consistently exceeded and met expectations, led, trained, and developed a 4-member IPQA team.

•  Provided support for regulatory GMP, USFDA, TGA, ANVISA, and customer audits.

•  Coordinated with production, quality control, and warehouse teams and overall shop floor in charge of quality checks.

To 

Education
Master of Business Administration, MBA General, Pondicherry University, Puducherry
Master of Technology, M.Tech, Biotechnology Jawaharlal Nehru Technological University, Hyderabad
Bachelor of Pharmacy, B.Pharmacy Jawaharlal Nehru Technological University, Hyderabad
Professional Development
Awards Ashland Service Award 10yrs, NPTEL Star evangelist, motivated learner, discipline star, believer, Topper 1% Elite Gold Silver 
DNV GL Business Assurance UK limited Lead auditor Certificate of training CQI IRCA approved
Post Graduate Diploma University of Hyderabad 
Communicative English, Chemical Analysis Quality Management, Planning and Project Management, Operations Management, Marketing Management, Human Resource Management, and Bioinformatics.
Online Course certification NPTEL (Ministry of Technical Education, IITs) SWAYAM (IIMB, CEC, NITTER) Quality Council of India
investigational new drugs clinical trials, legal regulatory issues in biotechnology, great experiments in psychology.
everyday psychology, happy and meaningful career, biomedical nanotechnology, new product development.
innovation startup policy, total productive maintenance, innovation information technology business environment.
continuous Quality Improvement (CQI) tools and techniques, innovation, business models, entrepreneurship.
talent acquisition management, body language for professional success, interpersonal skills, managerial dynamics.
six Sigma, managing change in organizations, knowledge management, soft skills, emotional intelligence, enhancing personality.
training of trainers, leadership effectiveness, effective writing, sociology of science, business sustainable development.
resource management, advanced corporate strategy, effective business communication, and business ethics.
Go lean six sigma Lean and Six Sigma Green Belt. ASQ  Member
Additional Information
International Business Trip, Industrial Oriented Training: Visited Ashland Global offices, manufacturing facilities in USA, UK, France, Belgium, Netherlands, Switzerland, Poland, and Singapore.
Skills: 
Action-oriented, customer-focused, results-driven, adapt rapidly to changes, deal with ambiguity, manage conflict effectively.
Interpersonal skills include active listening, integrity, and trust. I am organized, efficient, and committed to self-development.
Capabilities: 
Demonstrated techno-commercial expertise in quality control assurance, customer focus, and supplier quality management.
Successfully implemented ERP, collaborated with regional corporate teams, and implemented industry best practices.
Managed warehouse inventory, resolved issues effectively, and worked as a QA Specialist, Quality Assurance Engineer, Software Validation Engineer, In-Process Quality Assurance (IPQA) Specialist, and Document Control Specialist.
Computer Knowledge: SAP S4 HANA, LIMS, Track Wise, Pivotal CRM, System 21 JBA, MS Office, Lotus Notes, Product Suite.
Citizen of India Languages English, Hindi, Telugu    https www linkedin com/in/krishnamogulla/