Krishna Mogulla
reddy
Hyderabad/Secunderabad
Summary
Hyderabad, India In quest of challenging role in specialty chemicals, pharmaceutical industry to leverage the expertise and experience gained in quality assurance and operational excellence, contribute growth opportunities. QUALITY COUNCIL OF INDIA QCI Continuous Quality Improvement CQI Tools and Technique total productive maintenance NPTEL Course certification, Ministry of Technical Education IITs investigational new drugs clinical trials legal regulatory issues in biotechnology innovation business models entrepreneurship talent acquisition management body language professional success interpersonal skills managerial skills for interpersonal dynamics six sigma human behavior managing change in organizations knowledge management soft skills emotional intelligence enhancing soft skills personality training of trainers leadership team effectiveness effective writing sociology of science great experiments in psychology business and sustainable development psychology of everyday sociology of resource management biomedical nanotechnology SWAYAM certification courses, Government of India IIMB, CEC, NITTER managing innovation new product development student psychology innovation startup policy advanced corporate strategy effective business communication business ethics happy and meaningful career strategic management innovation and information technology business environment. ADDITIONAL INFORMATION Training Natco Pharma Limited Industrial Oriented Course. International business trip Ashland Global offices, manufacturing facilities. USA, UK, France, Belgium, Netherlands, Switzerland, Poland, and Singapore. Skills techno commercial regional and corporate team facilitator ability to adapt rapidly to changes action oriented dealing with ambiguity conflict management creativity customer focus decision quality informing Integrity and trust interpersonal listening organizational agility peer relationships perseverance priority setting process management drive for results self-development management of time
Overview
17
17
years of professional experience
Work History
PRINCIPAL
ITRADIANT SOLUTIONS PVT LTD
08.2022 - 02.2023
- EXPERTISE
- Established quality procedures, excellent in optimizing processes, sustain products delivery service to customers through continuous quality improvement, excellent rapport with internal and external customers for business success
- Generated standard information, statements, customer support simplified through quality standards responses to meet customer expectations, supply chain requirement; completed questionnaire, Specification, agreement requests
- Participated in supplier quality projects, risk assessment, and good at supplier evaluation and performing audits; applied various quality measures to ensure operational excellence, compliance with customer quality requirements
- Guaranteed correct plant and sales specification for all SKUs in LIMS, maintain SAP; instrumental in trouble shooting systems issues expertise in LIMS/SAP implementation; trained users on LIMS/SAP areas as global administration role
- Facilitated timely update on batch status, usage decision code, to support SMOG off grade, out of quality specification material stocks inventory control
- Prepared Standard Operating Procedures (SOPs), and guided preparation of BPRs
- Well conversant with quality management system
- Reinforced compliance status as internal quality audits team member and monitored status
- Chaired as in process quality assurance for shop floor inspection and compliance status, batch releases in SAP; analytical results and COA, BPR compliance, current GMP compliance during manufacturing, packaging operations
- Monitored process validation prepared process validation protocols, reports; tracked data for annual product review
- Administered samples, retest requests with the help of plants, using contract laboratories
- Implemented system to reduce customer complaints and improve timely closure of non-conformances; coordinated market complaints, change control, deviations, and incidents
- Maintained issuance, retrieval, storage and controls of documents and records; upkeep of IPQA and QA documentation
- Expanded knowledge on industrial guidelines, standards - USP, IPEC, EFFCI, EXCiPACT, BRC, FSMA, and HACCP USFDA; 21CFR Part 210 211; 21CFR Part11 & Annex11 FSSC 22000 ISO 9001:2015
- Integrated focus on quality through implementation of total quality management TQM, material resource planning MRP, sales and operational planning S&OP
- Supported timely release of master packaging record for the batch and approval of expiry date extension for the batches
- Adhere to compliance with cGMP in Technical Research and Development
- Support cases for the temperature excursions
- Collaborated with customers deep understanding of end-to-end Life Science business process, acts as an industry advisor
- Understand deeply company unique challenges and goals, expertise in SAP support for Life Science domain industries
- Life Sciences Industry Principal to support digital technology implementation consultant - Key Responsibilities and Deliverable
- Completed Validation documentation as part of preparation review and approval of documents, sign off
- Interacted with Customer and Coordination with SAP module teams for successful implementation projects
- Initiated and developed strong relationship with key partners in Life Science domain
- Managed proactively ongoing relationships of 2 customers to stay relevant to health care technologies vendors
- Benefited the entire 1 project team and enthusiasm for supporting business development initiatives
- Coordinated with 8 modules teams, project group of peers, clients, and analysis in a professional manner -Conducted training sessions for Life sciences project teams on GxP practices and collaborated with 2 offices across the globe.
QUALITY ASSURANCE MANAGER
NOVARTIS INDIA PRIVATE LIMITED
03.2021 - 12.2021
- Novartis Business Services (NBS) Key Responsibilities and Deliverable – Technical Research and Development IMP QA - External
- Reviewed of 20% Site temperature excursion for medication and providing the decision
- Conducted 20% Global Clinical Supply temperature excursion for medication and providing the decision
- Checked master batch record as per the SOP, Expiry date extension, 100% Complete the review checklist form
- Reconciled the 100% records archives in the IT system compliance with GxP documents
- Perform review of the batch master packaging records
- Review temperature excursion cases 180 per year
- Archived approval related documents in 2 databases iRelease, track wise
- Collaborate with 3 teams, members, and stakeholders
- Communicate actively contributes to team goals, address problems
- Executed in the system for 2 activities the master packaging batch records, approval of expiry date extension for the batch.
QUALITY ASSURANCE MANAGER
ASHLAND INDIA PRIVATE LIMITED
03.2009 - 12.2020
- Global Supply Base Quality Toll Manufacturing and Purchase for resale (PFR) Key Accomplishments
- Performed 12 warehouses 30% of products releases improved flow 18% by reduced time, allocation, and post goods issues
- Monitored status, usage decision, partnership with planning decreased slow-moving Inventory 8% per year saved disposal cost
- Assured sales specification setup for 650 codes correct, review change effect on inventory, issue notifications if necessary
- Managed 25% of products 850 in a year customer quality questionnaire, spec reviews, agreements, complaints, returns
- Provided quality input 50% weights on purchasing decisions in supplier selection, improves overall performance
- Executed supplier audits 12 in year evaluated risk assessment, verified questionnaires, specifications, agreements
- Exceeded expectations, 11+ years, 5 roles and 3 promotions! experienced
- Reorganized after merger acquisitions of $3.2 billion and 690 million, implemented ERP global project 3 months duration
- Streamlined process saved $1.5 million cost in 10 months by six sigma projects.
QUALITY ASSURANCE MANAGER ASSISTANT
- Manufactured 3 types of products manufacturing, toll, and purchase for resale (PFR) corporate quality assurance
- Supervised 8 global warehouses product releases in Asia Pacific, EMEA regions
- Minimized 28% slow-moving Inventory by material movement, shelf-life extension, downgrading, product risk management
- Facilitated EMEA Customer support 40% of global requests, completed 85% and remaining dealt with plant QA tracked time
- Acted as a backup for 9 plants QA managers, collaborated with 5 internal department stakeholders, external customers.
QUALITY ASSURANCE SPECIALIST
- Held accountable for product releases 6 regional warehouses in EMEA region for inbound goods receipt, outbound deliveries
- Arranged 20% of samples testing at 2 contract labs checked performance, assisted 15% supplier and customer complaints
- Reduced 18% inventory in 2 years with help of planning, sales, and customer support teams
- Handled specification changes 60 per year supplier specifications as per organization requirements.
QUALITY ASSURANCE CHEMIST
NATCO PHARMA LIMITED
09.2005 - 02.2009
- Pharma division formulations Solid dosage forms unit Quality Assurance IPQA, Documentation Compliance
- Achievements
- Ensured quality compliance at 4 manufacturing, packaging areas
- Handled change controls, deviations, market complaints
- Reviewed BPRs, Analytical Results COA, and released batches
- Compiled 10 per year Annual Product Reports summarized KPIs
- Inspected 12 products process validation in 24 months assured consistent quality
- Authored/Revised SOP, Master BPRs
- Conducted 4 internal audits in 2 years assessed compliance status
- Exceeded, met expectations consistently
- Lead, trained, developed 4 member IPQA team
- Provided support 4 regulatory GMP, USFDA, TGA, ANVISA and customer audits
- Coordinated with production, quality control and warehouse 3 teams and overall shop floor in charge for quality checks
- Involved in top 1 key oncology brands first to launch in India validation batches.
Education
Master of Business Administration, MBA - undefined
Pondicherry University
Master of Technology, M.Tech - Biotechnology
Jawaharlal Nehru Technological University
Bachelor of Pharmacy, B - Pharmacy
Jawaharlal Nehru Technological University
Skills
- Investigational Medicinal Products Batch Approval Expiry Date Extension Release of Master Packaging Record
- Temperature Excursion Cases Supplier Quality Evaluation Audits Customer Quality Continuous Quality Improvement
- Specification Setup LIMS SAP GMP Product Release Material Stock Inventory Control In Process Quality Assurance
- Documentation Compliance Manufacturing Packaging Operations Research Development
- Computer System Validations SAP S4 HANA Implementation
- PROFESSIONAL SYNOPSIS
- Demonstrated success with experience in planning, execution, application methodology and documentation
- Associated with Novartis, Ashland (global business shared services), Natco Pharma Limited;
- Extremely reliable, collaborative, and forward-thinking top-notch professional with pioneering 16 Years of experience;
- Acumen in implementing business goals, monitoring aspects of supply base quality, in-process quality assurance
- Computer Knowledge
- LIMS, SAP, Track Wise, Pivotal CRM MS Office, Lotus Notes, Product Suite, JBA System 21 SAP S4 HANA
- Capabilities quality control, quality assurance, customer focus, inventory, and risk management
- FOR RECRUITERS Citizen of India Languages English, Hindi, Telugu https://wwwlinkedincom/in/krishnamogulla/
Affiliations
Appreciation Awards Service Award 10years.
NPTEL Star Awards Evangelist motivated learner discipline star believer enthusiast Topper 1% Elite Gold Silver
Timeline
PRINCIPAL
ITRADIANT SOLUTIONS PVT LTD
08.2022 - 02.2023
QUALITY ASSURANCE MANAGER
NOVARTIS INDIA PRIVATE LIMITED
03.2021 - 12.2021
QUALITY ASSURANCE MANAGER
ASHLAND INDIA PRIVATE LIMITED
03.2009 - 12.2020
QUALITY ASSURANCE CHEMIST
NATCO PHARMA LIMITED
09.2005 - 02.2009
QUALITY ASSURANCE MANAGER ASSISTANT
QUALITY ASSURANCE SPECIALIST
Master of Business Administration, MBA - undefined
Pondicherry University
Master of Technology, M.Tech - Biotechnology
Jawaharlal Nehru Technological University
Bachelor of Pharmacy, B - Pharmacy
Jawaharlal Nehru Technological University
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