About Gobind Jayesh:
I've been working as a Quality Assurance and Regulatory Affairs Engineer for Medical Device Manufacturers for the past two years. Currently I'm in search for a job in Dubai, Abu Dhabi or Sharjah.
Experience
Company: Dr. Pack India Pvt Ltd
Designation: Engineer - Quality Assurance, QMS, and Regulatory Affairs
Job responsibility:
- Establish Policies in-line with company mission and values.
- Prepare and update QHSE system procedures, work instructions, standard operation procedures (SOPs) and formats as per requirement.
- Assist in the development, implementation and monitoring of Integrated QHSE Management System that complies with Company policies and procedures as well as client requirements.
- Planning and conducting QHSE internal audit in accordance with guidelines as per ISO Standards.
- Conducting On-site Supplier/Vendor QHSE Audits.
- Conduct incident investigations and analysis to identify the root cause of incidents, provide appropriate corrective actions and prepare/submit lessons learned to the QHSE Manager.
- Initiate, Review, and finalize the projects/Activities/Services Risk Assessment, Environmental Aspect & Impact Register.
- Assist in the preparation of legal & compliance register and to support all departments and the company to be in conformance with relevant legislations and mandated requirements.
- Responsible for Regulatory Compliance and preparation, review and timely submission of dossiers to various agencies.
- Handle customer complaints and implement Corrective and Preventive action using Quality tools like Pareto, Control Charts & verifying its effectiveness.
- Provides regulatory guidance to regulatory associates & other departments.
Education
EDUCATION and TRAINING
- Bachelor of Technology in Mechanical Engineering
Cochin University of Science and Technology, 2020
CERTIFICATIONS
- Lead Auditor Certification in ISO 9001:2015
- Internal Auditor Certification in ISO 45001:2018 and 14001:2015
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