PROFESSIONAL SUMMARY:

• Quality Management & Global Compliance Quality Budget Preparation & Expenses control System Harmonization and Training Motivating & Leading Team Spearheading Plant Project
• Detail - oriented and analytical professional with 21+ years of rich experience in Quality Functions, Quality Compliance, Pharmaceutical Formulation and Regulatory Affairs within Pharmaceutical, Dietary Supplement and Nutraceuticals Industry at International level
• Hands-on experience in regulatory compliance, International Regulatory and Customer Audits
• Profound knowledge of regulatory publishing standards, procedures current and regulatory submission requirements
• Insightful knowledge of various types of biological techniques, QC laboratory, Global Quality, CAPA Compliance, research and technologies of modern drugs in accordance with bio analytical method validation guidelines
• Adept at developing plans and methods for quality improvement process including Quality Documentation, Lead Quality investigation, Quality Risk Assessment, Validation and Qualification (process, equipment, utility) and safety
• Excellent ability to work well in a team environment with exceptional leadership and organization skills that generate a productive work environment
• Abreast with national and international legislation, guidelines and customer practices across pharmaceutical industry and articulate in communicating information with manufacturers on regulatory requirements
• CAPA Compliance
• Quality Compliance & Assurance
• Quality Auditing
• Vendor Audit and development
• CMO Auditing
• Software Implementation & Qualification (CSV)
• Quality Control and Application
• Life Cycle Management of Drug Product
• Risk Management
• Health and Safety Regulations
• Audit & Analysis
• Stakeholder Management
• Quality Inspection
• Defect Tracking
• Report Review
• Production Planning
• Strategy Planning
• Team Management
• Training and Implementation Client Relationship Management
• Experienced in interacting with onshore and offshore team and clients for better execution of project
• Successfully worked in cross-functional team environments and with people from diversified backgrounds & geographies
• Played a pivotal role in data integrity and Record room data control
• Dexterously represented QA and CQA functions and various Validation and Qualification Documents in Audits
• Harmonization of integrated QMS and other quality systems within Organization
• Implemented Electronic system for Training, SAP, Artwork, Documentation and Quality QMS
• Delivered training and established Lab-QA for QC compliance
• Successfully Established the Yield determination and improvement
• Development of qualification and validation documents based on risk approach
• Established successful team for Global Quality Compliance and Global CAPA compliance in Confidential with achievable concepts and procedures.

TECHNICAL COMPETENCIES:

Proficient in: Microsoft Office Applications, AutoCAD. Smart Solve (Pilgrim Quality Management), PERP, WMS, SAP, Mini Tab-16. Adobe Acrobat Professional XI Pro. Pharma Ready, Track and Trace, Caliber eTMS, eDMS, Sparta-Track Wise -QMS

Self-developed simplified electronic documentation systems for handling of: GMP documents (as Batch record, QC record, QMS, PQR, Training, Document Control and Issuance,) using Microsoft Access and visual basic knowledge

PROFESSIONAL EXPERIENCE:

Confidential

Asst. General Manager QA

Responsibilities:

• Establishing the plant quality operations for Myanmar OSD site for Regulatory Market
• Working with Myanmar Team of manufacturing and quality leadership to execute the product quality strategy ensuring CPM and return rate improvements
• Succeed in partnering cross-functionally within Confidential Myanmar and across the global business
• Analyze and update the end-to-end product development and manufacturing process and drive strategies that reduce product variability and Cost evaluation
• Develop a complaint process that ensures consistent quality products & creating and implement process control strategies that improve process variability and ensure quality assurance
• Designing a statistical process control strategy and train all employees in its execution
• Collaborating with other functional leaders to develop the quality strategy to drive continuous improvement into processes that includes planning, product design and development facilities
• Providing the company with insight into opportunities for quality and cost improvement relating to product lines, while ensuring all applicable standards and regulations are met
• Driving the development of internal networks that foster quality, risk management and compliance
• Guiding and overseeing the prioritization and resource management relative to company-wide quality objectives
• Ensures a superior interface between the quality function and distribution, marketing, manufacturing, product development, and other key stakeholders
• Ensures internal processes and metrics are aligned to create high product and service quality and competitive advantage
• Steering quality, policies, strategies and benchmarks for the business that facilitate an unyielding commitment to quality
• Involve in continuous improvement culture and engages senior management to role model a continuous improvement mindset
• Identifying and articulating the links between continuous improvement and business objectives to facilitate business awareness
• Setting standards for achievement of continuous organizational improvement to ensure systems scalability and alignment with business objectives

Confidential

Sr. Manger QA

Responsibilities:

• Led review of existing system and processes and conduct Quality Risk Management for new process and equipment and conduct discussions with site QA heads on improvement action plan and ability to resolve issues.
• Coordinated and execute validation aspects for key site projects to implement new equipment, technology, Software, processes or materials as per business needs
• Conducted National and International Vendor Audits for Raw material and Packing material, CMO, Equipment manufacturer, Suppliers and Service Providers
• Developed CQA SOP and implement integrated QMS and harmonization of procedures across sites
• Represented the company for QMS and Quality Software at regulatory inspections respond to questions, co-ordinate responses and ensure compliance to corrective actions as appropriate
• Led Investigation activities of deviation, Market complaint, Lab Incidents, OOS with a well-defined scope, strategy, and timeline documenting status and progress of the investigation and CAPA approval and Global CAPA extension to other sites and effectiveness checks
• Utilized the appropriate and approved investigation tools necessary to drive the team to root cause. Prioritizes work to aid in timely decisions and completion of investigations. Escalates issues to top management
• Conduct and co-ordinate various training program for employees as per their training and talent needs on standards of GMP, GDP, Data integrity and other technical subject competency by coaching and developing
• Conducting technical interview and supporting recruitment and development of new talent to fill competency gaps.
• Spearheaded project head for implementation of electronic Quality system for Training (eTMS), Documentation (eDMS), and QMS (TrackWise), LIMS CDC for Specifications with harmonized approach across all sites of Confidential
• Enhancement of other electronic system as OOS/Validation, Qualification, Calibration and APQR by track wise and approval of CSV
• Initiated developing SME - Subject matter expert program for various technical areas as Validation, Qualification, Auditing, QMS, APQR, QRM, Investigation and conducting technical and compliance meetings with SME across sites
• Reviewed and approval of Plants Quality Review Matrix on monthly basis and conducting Quality meeting with Plant QA heads and top management for escalation of issues and ensure compliance
• Responsible for Scheduling, conducting, training, self-inspection and global CAPA verification across all sites
• Developed new training modules on elements of GMP W.R.T SOPs and conducting training to sites
• Key role in reviewing, Approving, extending and escalating day to day Quality issues to Head CQA and President Quality
• Involved in making new quality strategies developing Quality Culture at manufacturing sites under guidance of the CQA Head and President Quality