GRUFIN JOHNSON DABRE
Guelph,Canada
Summary
Results-oriented professional with a Bachelor's degree in Mechanical Engineering and Ontario Graduate in Quality Engineering Management. Extensive experience in Pharmaceutical Manufacturing Operations, including 5 years of hands-on experience and 3 years of successful supervision of unionized technicians. Recognized as a Certified Process Quality Analyst by the American Society of Quality. Skilled in conducting Health Canada , Internal Quality Audits, Gemba Audits, and Workplace Safety Inspections. Demonstrated track record of designing, leading, and executing continuous improvement initiatives. Proficient in SAP, CMMS Maximo, Quality Management System, AutoCAD, and Microsoft Office tools. Strong verbal and written communication skills with a focus on research and presentation abilities to effectively convey complex information.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Facility Compliance Coordinator
Johnson & Johnson Consumer Health
04.2023 - Current
- Lead investigations, CAPA and change controls ensuring quality and accuracy of documentation as well as adherence to established due dates.
- Lead the department record retention activities, write Standard Operation Procedures and risk assessments.
- Support contractors GMP compliance, compliance with ontario provincial codes, TSSA, ESA authorities.
- Supervised contractors, technicians in achieving operational excellence through effective leadership and performance management
- Implemented and maintained safe systems of work, ensuring compliance with JHSC , Safety regulations and fostering a culture of safety consciousness.
- Lead installation, trails and qualification protocols for equipment and facility qualifications.
- Drove continuous improvement initiatives to enhance productivity, reduce waste, and optimize operational processes, resulting in achievement of productivity goals.
- Prepare and present analysis related to asset management, maintenance management in CMMS Maximo.
- Interface regularly with Quality Assurance, EHS, Manufacturing, Packaging and other functional areas in order to remove obstacles, resolve issues, and to help facilitate critical decisions pertaining to compliance
- Collaborate with training specialists regularly to mitigate any compliance risks associated with the Facilities training program.
- Continually reassess Facilities HVAC, Purified Water Systems, Building Automation Systems, Compressor Systems for adherence to cGMPs and Company standard methodologies and implement changes/improvements as needed
- Organize Monthly Gemba walks to identify and report safety good saves and incidents in JHSC database.
- Oversee Plant shutdowns , project development tasks while meeting the project timelines.
North America External Manufacturing Quality Co-op
Johnson & Johnson Consumer Health Inc.
08.2022 - 04.2023
- Collect and review quality documentation against pre-determined specifications, analyzing and reviewing certificates of analysis, and certificates of manufacture for product approval
- Prioritizing Out of Stock Product Batches working with cross functional teams for timely release of Priority SKU's
- Work with the internal quality team to support initiatives with internal and external suppliers and manufacturers on quality related issues
- To adhere to GMP Practices and ensure compliance with internal procedures and external regulations is followed
- Initiate and provide support to various continuous improvement processes
- Revising, Creating Packaging, Manufacturing work instructions
- Supports product qualification and validation activities as part of ongoing support to marketed products well as new product launches
- Achieving maximum OTIF and maintaining, analyzing data towards Weekly and Monthly Metrics, and publishing them to the stakeholders
In Process Quality Control Supervisor
ACG Associated Capsules Ltd.
12.2018 - 05.2021
- Monitor and review In Process quality control checks to meet the required quality compliance as per specifications
- Partnering with Planning, Operations and Manufacturing teams to improve process efficiency and eventually reducing machine downtimes
- Led a team of 20 technicians in rotational shifts
- Track instance of repeat failure from operators and set processes to avoid re-occurrence of the same and to ensure FTR
- Decision making on Product Quality, Data Collection and to do Analysis of Process Parameters with Control Charts for Continuous improvements and Defect Reduction
- Implementing and facility auditing of SOP compliance,5S, OSHA, Good Manufacturing and Good Documentation Practices
- Performed root cause analysis by PDCA, Ishikawa for the resolution of non-conformances and customer complaints with very high attention to details
- Auditing and Publishing Critical to Quality Metrics to the Stakeholders to identify Process Bottlenecks
- Following and implementing Corrective and preventive actions (CAPA) to avoid external failures
- Ensuring QMS and ISO 9001, 14001 and 45001 standards compliance is followed
Education
Post Graduate Diploma - Quality Engineering Management
Lambton College
Toronto, Ontario04.2023
Bachelor of Science - Mechanical Engineering
University of Mumbai
Mumbai06.2018
Skills
- Regulatory knowledge
- Compliance Monitoring
- Technical writing
- Legal Research
- Audit Coordination
- Auditing
- Quality Management Processes
- Internal Audits
- Conducting investigations
- Vendor / Supplier Performance Management
- Process Development
- Facility Inspection
- Root Cause Problem Solving
- Engineering Change Controls
- Process Control and Risk Management
Accomplishments
- Successfully led Global Quality Management System for Equipment Calibration and Preventative Maintenance.
- Created PowerBI Metrics dashboard for Preventative Maintenance Compliance.
- Trained Facilities technician and Contractors for Good Documentation as per Health Canada (GUI-0104).
- Facilities Project lead for Capital Projects, Facility Qualifications, Equipment Validations and Qualifications.
- Part of Project team to tackle supply chain disruptions for ibuprofen and acetaminophen Shortage in Canada 2022-2023.
Volunteer Experience
- Lead for Johnson & Johnson Canada Cultural team
- Volunteer for City of Toronto - Arts and Culture
- Summer Soccer Coach at Guelph Soccer
- University Of Mumbai National Social Service Volunteer.
- Head for Waste management and Green Campus Project.
Languages
English
Native or Bilingual
Hindi
Full Professional
Certification
American Society of Quality Certified Quality Process Analyst
Working at Heights
Hazardous Material Certified
Timeline
Facility Compliance Coordinator
Johnson & Johnson Consumer Health
04.2023 - Current
North America External Manufacturing Quality Co-op
Johnson & Johnson Consumer Health Inc.
08.2022 - 04.2023
In Process Quality Control Supervisor
ACG Associated Capsules Ltd.
12.2018 - 05.2021
Post Graduate Diploma - Quality Engineering Management
Lambton College
Bachelor of Science - Mechanical Engineering
University of Mumbai
American Society of Quality Certified Quality Process Analyst
Working at Heights
Hazardous Material Certified
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