BHAVIK GOHIL
Saskatoon,Canada
Summary
A highly efficient, hardworking Personal who has considerable experience of developing and implementing effective quality procedures in a manufacturing and corporate environment is looking for a challenging and rewarding position that leverages my education, experience and technical skills in ways . Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
14
14
years of professional experience
Work History
Quality Assurance – HACCP Specialist
Maple Leaf Foods Inc.
06.2018 - Current
- Perform and/or assist in daily quality and food safety related decision making based on established processes to ensure products meet the quality standards and food safety requirements of Maple Leaf Foods and its customers
- Responsible for product holds for non-conforming product and collecting information to assist in determining product disposition
- Perform daily monitoring and verification tasks, including record review and on-site audits/observations, as outlined in the HACCP program and recommend corrective actions for deviations
- Conduct plant audits to ensure GMPs and plant policies are effectively implemented
- Participate in external and internal audits as required
- Assist CFIA in completion of Compliance Verification System (CVS) tasks by providing records and information as requested
- Participate in product traceability events with the ability to quickly trace product using SAP
- Prepare sensory samples and participates in sensory evaluations
- Participate in projects and meetings with the goal of improving food safety and food quality
- Assist in the implementation of changes that advance FSQA systems and/or programs
- HACCP/QA documentation review (paper and electronic review and verification)
- Daily on-site support to sanitation and pre-operational employees by completing pre-op inspections, coaching/training sanitation and pre-op, identifying risks and areas for improvement on sanitation/pre-op
- Assisting in TPC and lactic swabbing as required, particularly for special investigations
- Provide Food Safety training, orientation, and guidance to plant and salaried employees, and visitors
- Monitor for compliance to GMPs through on-floor inspections and audits
- Support other roles in FSQA team as required
- Hold and Release of product through SAP
- Conduct monthly meetings
- Create, design, implement written programs under the leadership of FSQA Supervisor
- Actively involved in day to day tasks to support operations.
Quality Control – Senior Executive
Lupin Limited
08.2018 - 01.2020
- Supervise compliance to all cGMP, GDP, GLP or any other Regulatory Requirements
- Review of Quality Records Viz
- Batch Records, Machine Log cards and Room Log cards
- Review QMS documents Viz
- Change Control, Deviations, CAPA etc.
- OOS, OOT, Deviation Handling, Investigation of Incident and CAPA implementation
- Handling of SOPs about Training of SOPs, Writing of SOPs, Ensuring Review of SOPs and Approval before due dates, Need for Identification and Training, Ensuring Approval of Internal Trainers
- Training of Employees, Maintaining Training Matrix through Training Management System Software, Induction Training, On-Job Training and Training related Records Management
- Training Scheduling, Co-ordination, Conduct and Log of Training with attendance documentation, Preparation of Training materials such as Quality Modules
- Handling of Quality Improvement project and meetings to achieve the company’s goal
- Preparation of COA, Daily Reports, Certificate of Analysis, Trend Data, Qualification/Validation documents and Annual Product Quality reports
- Conduct and face audits like Regulatory Audits (USFDA, CDSCO, ISRS, FDA) and Customer Audits.
Quality Control – Senior Officer
Alkem Laboratories Limited
12.2014 - 08.2018
- Supervise compliance to all Regulatory Requirements
- Review of Quality Records Instrument Usage Log, Area Monitoring Logs etc
- Initiation and review of documents related to OOS, OOT, Deviation, Investigation of Incident and CAPA implementation
- Preparation and review of SOPs, Certificate of Analysis
- Qualification documents, Validation documents and documents related to Training of SOPs along with Approval before due dates, Need for Identification and Training, Ensuring Approval of Internal Trainers
- Self Inspections (Internal Audits)-Planning, Approvals, Scheduling, Execution, CAPA compliance from various departments
- Supporting QC/QA Manager in achieving and maintaining compliance to quality Systems and procedures and regulatory requirements
- Look out the internal and external calibration & validation related activity & maintain the microbiology area as per GMP
- Performs Microbiology Analysis of Raw Water, Process Water, Potable Water, Purified Water, Intermediate Product, Finished Product and Environment etc.
Quality Control – Officer
Glenmark Generics Limited
01.2010 - 12.2014
- Look out the internal and external calibration activity & maintain the microbiology area as per GMP
- Perform microbiological and analytical sampling for water, product and environment
- Performs Microbiological analysis of Potable Water, Purified Water, WFI Water, Finished Product, Stability Samples and Environment
- Operation, Calibration, Validation and Qualification of Instruments like Total Organic Carbon Analyzer (Shimadzu), Steam Sterilizer, Dry Heat Sterilizer, pH Meter, Weighing Balance, Laminar Air Flow, Incubators etc.
- Maintenance, Preservation & Preparation of Microbial Culture and Culture Suspensions, Cell Enumeration, Storage & Destruction
- Trend data preparation for water analysis and environment monitoring
- Area Qualification and Water System Qualification
- Media preparation and Growth Promotion Testing of culture medias
- Participate in projects to achieve company’s goal.
Education
Master of Science (Microbiology) -
Padmashree Institute of Management and Sciences
Bangalore, Karnataka06.2009
Post Graduate Diploma in Medical Laboratory Technology -
Bio-Tech Institute of Medical Technology
Surat, Gujarat04.2007
Bachelor of Science (Microbiology) -
Sarvajanik Institute of Computer Education
Surat, Gujarat03.2006
Skills
- Good Understanding of GXP (cGMP, GLP, GDP) Standards, USFDA - 21 CFR Part 11: Electronic Records and Electronic Signatures, 21 CFR part 210 and 211, EU GMP, ICH Guidelines
- Excellent Computer Skills and Proficiency in MS Word, Excel and PowerPoint
- Strong Organizational skills, Interpersonal written and oral Communication skills
- Shop floor activities like In-process Quality Control, Guidance to Production Personnel about GMP and GDP and Data Integrity, Assurance of GMP Compliance on shop floor
- Qualification, Validation, Change Controls, Deviations, OOT, OOS and CAPA implementation
- Plan, Co-ordinate, conduct and log of trainings on all SOPs of department, Training of Employees and Casual Workers
- Easy understandings of Quality Software used commonly in Pharmaceutical Industry such as Training Management System, SAP, QAMS and LMS etc
- Superior multitasking, trouble shooting, flexible and organizational skills in order to meet the needs of departments and organization
- Demonstrative ability in Microbiology analysis
- Documentation Management
- Idea Development and Brainstorming
- Audit reporting
- Time Management
- Teamwork and Collaboration
- Supervision and leadership
- Troubleshooting
- Decision-Making
Languages
English
Full Professional
Hindi
Full Professional
Gujarati
Native or Bilingual
Timeline
Quality Control – Senior Executive
Lupin Limited
08.2018 - 01.2020
Quality Assurance – HACCP Specialist
Maple Leaf Foods Inc.
06.2018 - Current
Quality Control – Senior Officer
Alkem Laboratories Limited
12.2014 - 08.2018
Quality Control – Officer
Glenmark Generics Limited
01.2010 - 12.2014
Master of Science (Microbiology) -
Padmashree Institute of Management and Sciences
Post Graduate Diploma in Medical Laboratory Technology -
Bio-Tech Institute of Medical Technology
Bachelor of Science (Microbiology) -
Sarvajanik Institute of Computer Education
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