TrackWise
SUNIL MURKIKAR
Pharmaceutical
Yangon,Myanmar
Summary
PROFESSIONAL SUMMARY
Dedicated Pharmaceutical Industry professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
To seek and maintain full-time management position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Experienced General Manager Quality Operations with over 23 years of experience in highly regulated Pharmaceutical Manufacturing, Quality and Regulatory Affairs. Excellent reputation for resolving problems and improving customer satisfaction.
Overview
23
23
years of professional experience
6
6
years of post-secondary education
4
4
Languages
Work History
General Manager Quality Operations
Pacific Pharmaceutical Limited
Singapore, Singapore
11.2018 - Current
- Present Assignment Myanmar and USA
- Reporting to CEO and MD on Quality Operations and compliance
- Held overall responsibility for cGMP compliance for Pacific Pharmaceuticals Manufacturing Sites at Myanmar for Drug products marketed within Myanmar and OTC for United States
- Hosting of regulatory agency inspections and customer audits
- Responsible for all responses & corrective action plans to address any observations subsequent to inspection or audit
- Harmonizing Quality Standards as well as implement Management Policies at plant level
- Effectively educated employees for implementation of Quality System Management program and monitoring to provide visibility to senior management on current level of compliance
- Hold Responsibility of Management Representative for implementation and Compliance of ISO 9001:2015 and ISO/IEC 17025:2017
- Responsible for Regulatory Affairs and Product registration in ACTD at Myanmar and Export with oversight along with FDA compliance, and Business Expansion
- To performs cGMP audits of manufacturing site and vendors, suppliers, Contract Manufacturing Site
- Coordinates with all cross-function departments for corrective and preventive actions (CAPA)
- Acts as Lead Auditor for cGMP, ISO regulatory inspections at manufacturing site
- Ensures that Pacific Pharmaceutical is continually in state of cGMP inspection readiness by driving quality compliance of all applicable cGMP Regulations
- Drive improvements in Key Performance Indicators.
- Manage Quality departments and optimize resources in each area
- Formalize goals and objectives for both Quality departments QA, QC and RA
- Mentor and improve quality resource knowledge and skillsets
- Responsible for onboard QMS and Quality training for all employees
- Quality Operations of Pacific Group manufacturing sites and Contract Manufacturing Operations
- Establishing plant quality operations for Myanmar site for Regulatory Market WHO, Eu GMP, and US OTC
- Direct Reported by team of Quality Assurance, Quality Control (Chemical, Microbiology) and Regulatory Affairs of Pacific Myanmar Site
- Established Quality Control Laboratory and Analytical Research Laboratory of Pacific Myanmar and Achieved Accreditation of ISO/IEC 17025:2017 by ANAB USA for 33 Tests including Chemical and Microbiology Analysis
- Quality leadership to execute product quality strategy ensuring Competitive Profile Matrix (CPM) and return rate improvements
- Analyze and update 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 statistical process control strategy and training all employees in its execution
- Collaborating with other functional leaders to develop quality strategy to drive continuous improvement into processes that includes planning, product design, and development facilities
- Providing company with insight into opportunities for quality and cost improvement relating to product lines, while ensuring all applicable standards and regulations are met
- Primary Contact and coordinates regulatory agencies for compliance and approvals
- Driving development of internal networks that foster quality, risk management and compliance
- Guiding and overseeing prioritization and resource management relative to company-wide quality objectives
- Ensures superior interface between quality function and Production Planning, Regulatory Affairs, Quality Control, Manufacturing, distribution, marketing, 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 business that facilitate unyielding commitment to quality
- Involve in continuous improvement quality culture and engages senior management
- Identifying and articulating 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
- Accomplishments in Pacific:
- Established Quality Systems in New Plant
- Successfully led ISO 9001:2015 SIS in 2020
- Successfully led Contract Testing Quality Control Lab and achieved ISO/IEC accreditation 17025:2017 ANAB in 2022
- Successfully led GMP certification of Plant in 2021
- Establish Quality and cGMP procedures, product specifications with harmonized approach to meet multiple regulations across world USFDA, WHO, MHRA and TGA, ISO, ISPE, USP, BP, Ph Eur.
- Trained and mentored Quality and Production personnel to lead successful project teams
- Led Regulatory Affairs Department and Achieved 137 Dossier Submission and 97 product approval in 24 months.
- Led projects and analyzed data to identify opportunities for improvement.
- Prepared variety of different written communications, reports and documents.
- Actively listened to customers' requests, confirming full understanding before addressing concerns.
General Manager Corporate Quality
Alkem Laboratories Limited
Mumbai, Maharashtra
09.2014 - 10.2018
- Responsible for reviewing and approval of QMS of manufacturing sites and Laboratories, R&D, CDC & CQA
- Led Site CQA team 0f 17 Managers and Asst Managers and conducted Global CAPA Compliance across sites of Alkem by Total Corporate Quality Governance and empower Quality Culture
- 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 100+ 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 company for QMS and Quality Software at regulatory inspections (internal, external including USFDA & MHRA), 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 well-defined scope, strategy, and timeline documenting status and progress of investigation and CAPA approval and Global CAPA extension to other sites and effectiveness checks
- Utilized appropriate and approved investigation tools necessary to drive 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 Alkem
- Enhancement of other electronic system as OOS/Validation, Qualification, Calibration and APQR by track wise and approval of CSV
- Responsible for Scheduling, conducting, training, self-inspection and global CAPA verification across all sites
- Developed 23 new training modules on elements of GMP W.R.T SOPs, 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 CQA Head and President Quality
- Monitoring global budgetary activities for CAPEX as well as revenue items for various sites for Annual Quality Budget and Corporate Quality Budget.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
- Developed team communications and information for meetings.
- Managed team of employees, overseeing hiring, training and professional growth of employees.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Used coordination and planning skills to achieve results according to schedule.
- Offered friendly and efficient service to customers, handled challenging situations with ease.
- Actively listened to customers, handled concerns quickly and escalated major issues to supervisor.
- Carried out day-to-day duties accurately and efficiently.
- Resolved conflicts and negotiated mutually beneficial agreements between parties.
- Prepared variety of different written communications, reports and documents.
- Developed and implemented 11 performance improvement strategies and plans to promote continuous improvement.
- Led 4 projects and analyzed data to identify opportunities for improvement.
- Created plans and communicated deadlines to complete projects on time
- Demonstrated respect, friendliness and willingness to help wherever needed
- Identified issues, analyzed information and provided solutions to problems
- Increased customer satisfaction by resolving issues
Sr. Manger QA/QC
Micro Labs Ltd, OSD, Injectables
Verna, Goa
04.2012 - 09.2014
- Responsible for New facility project
- Quality compliance as per USFDA and SRA
- 150+ Equipment Qualification Activities and Approval
- 20+ New Product Process Validation Activities and Approval
- 250+ Employees Education and training to Employees on new Systems
- Established 750+ New SOP's and Quality Systems in New Facility
- Conducted and Led 50+ Management review meetings
- Regulatory Affairs
- 36+ New Product Registration Review
- Regulatory Compliance
- CAPA Management
- QMS Review and Approval
- Engineering Compliance
- Safety Compliance Management
Head of QA and Lab QA Unit
Cipla Ltd
Verna, Goa
01.2011 - 04.2012
- Responsible for Quality Operations
- Increased level of Quality Compliance
- Performed Global CAPA Compliance
- Handled Site Project Management
- Established new Quality Systems and Process
- Conducted 100+ Employees Trainings
- CGMP Compliance
- Used coordination and planning skills to achieve results according to schedule
- Conducted research, gathered information from multiple sources and presented results
- Resolved problems, improved operations and provided exceptional service
- Maintained excellent attendance record, consistently arriving to work on time
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Improved operations through consistent hard work and dedication
- Maintained energy and enthusiasm in fast-paced environment
- Participated in team-building activities to enhance working relationships
- Developed team communications and information for meetings
- Identified issues, analyzed information and provided solutions to problems
Manager QA/QC
ODS, Injectables, Sigma Laboratories Ltd
Mapusa, Goa
02.2007 - 12.2010
- Led New Project of OSD, Injectable, Ointments and Creams
- Implemented new quality assurance and customer service standards
- Cooperated with engineering, manufacturing and corporate accounting to verify adherence to quality standards
- Recorded, analyzed and distributed statistical information
- Assured consistent quality of production by implementing and enforcing automated practice systems
- Inspected products and worker progress throughout production
- Evaluated interactions between associates and customers to assess personnel performance
- Collected production samples regularly and performed detailed quality inspections
- Monitored staff organization and suggested improvements to daily functionality
- Applied coaching techniques and tools to support managers and team members in improving performance
- Tracked quality issues with external customers, suppliers and internal plant operations
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production
- Established and tracked quality department goals and objectives
- Implemented ISO 9000 quality systems, defining business practices, leading to certification and better business practices
Asst. Manager QA/QC
Mylan, Matrix, laboratories limited, ODS and Injectables
Nashik, Maharashtra
11.2003 - 01.2007
- New Facility Project Management
- Qualification Activities
- Validation Activities
- Documentation Control
- Quality Assurance
- Batch Release
- Regulatory Filing Preparation and Review
- Product Dossier Preparation
- Local FDA Licensing Activities
- Quality Control Activities
- Stability Testing
- Microbiology Testing
- Chemical Analysis
Education
Lead Assessor ISO 17025:2017 - Testing And Calibration Laboratory
ANAB USA
USA 03.2022 - 03.2022
ISO Lead Auditor 9001:2015 - Quality Management System
TUV Nord
India 03.2016 - 03.2016
Master Degree - Pharmaceutical Technology
Vinayaka Mission University
India 01.2008 - 01.2010
Some College (No Degree) - Chemical and Instrumentation
Maharashtra - FDA
Nashik FDA 04.2006 - 04.2006
Bachelor Degree - Pharmacy
Gulbarga University
India 11.1994 - 11.1998
Skills
CGMP Compliance
Competent to USFDA, WHO Geneva, MHRA, TGA, EU, HEALTH CANADA and ANVISA compliance
New Facility Project Management
Corporate Quality Governance
Leadership Skills
Experience in Quality Functions (QA/QC), Quality Compliance, Pharmaceutical Formulation (OSD, Injectables, Ointments and Liquid Orals, Powders) and Regulatory Affairs within Pharmaceutical, Dietary Supplement and Nutraceuticals Industry at International level
Global CAPA Compliance
Quality Assurance
Quality AuditingVendor Audit Vendor Development
CMO AuditingSoftware Implementation & Qualification (CSV)Quality Control and ApplicationProduct Life Cycle Management
Risk ManagementHealth and Safety RegulationsAudit & Compliance Analysis
CFT and Stakeholder Management
Quality InspectionInvestigation of Deviation, OOS, OOT, OOC
Management Review
Production PlanningStrategy PlanningTeam ManagementTraining and ImplementationClient Relationship ManagementBatch ReleaseTime ManagementResource ManagementKnowledge of ICH, GxP GLP, GDP Compliance
ISO 9001, 17025, 13484, 14001, 45001, 22000Compliance
Data Integrity Compliance
Project Director and Management
People management
Business Development
Pharmaceutical Regulatory Affairs
Validation Qualification Activities
Computer System Validation 21 CFR 11 Compliance
Quality assurance recordkeeping
Food preparation and quality
Food quality assessments
Offensive operations
Firefighting operations
Accomplishments
- ISO 17025 Accreditation of Testing laboratory by ANAB USA in Myanmar
Software
SAP
Microsoft Office
EDMS
LIMS
Timeline
Lead Assessor ISO 17025:2017 - Testing And Calibration Laboratory
ANAB USA
03.2022 - 03.2022
General Manager Quality Operations
Pacific Pharmaceutical Limited
11.2018 - Current
ISO Lead Auditor 9001:2015 - Quality Management System
TUV Nord
03.2016 - 03.2016
General Manager Corporate Quality
Alkem Laboratories Limited
09.2014 - 10.2018
Sr. Manger QA/QC
Micro Labs Ltd, OSD, Injectables
04.2012 - 09.2014
Head of QA and Lab QA Unit
Cipla Ltd
01.2011 - 04.2012
Master Degree - Pharmaceutical Technology
Vinayaka Mission University
01.2008 - 01.2010
Manager QA/QC
ODS, Injectables, Sigma Laboratories Ltd
02.2007 - 12.2010
Some College (No Degree) - Chemical and Instrumentation
Maharashtra - FDA
04.2006 - 04.2006
Asst. Manager QA/QC
Mylan, Matrix, laboratories limited, ODS and Injectables
11.2003 - 01.2007
Bachelor Degree - Pharmacy
Gulbarga University
11.1994 - 11.1998