Johnson Misquith
Manufacturing Quality Assurance Associate-1 @ Baxter International Inc.
About
Quality Assurance Professional with over 11 years of experience in Pharmaceutical Quality Management including GMP Compliance, Auditing, and Continuous Improvement. My career has been dedicated to enhancing the quality and safety of medicines, ultimately improving patient and consumer outcomes. At Baxter in Alliston, Ontario, I lead the Quality Operations for my shift, I handle over all quality tasks that also includes decision making on quality issues, Quality Management System, Documentation review, System, Facility and Utility breakdown review, Change Control and Incoming materials review, Periodic Compliance Walk, Cross-Functional Training and Particulate Matter Identification. At Trillium Health Care Products in Brockville, Ontario, I lead the investigation of deviations and customer complaints, ensuring the highest standards of quality and compliance at our site. Previously, as a Junior Manager at Syngene International Limited, I collaborated with a skilled team of QA professionals to uphold the quality and compliance of pharmaceutical products and processes. My M.Pharmacy in Quality Assurance has equipped me with a solid foundation in various compliance systems, including TrackWise, SAP, Electronic Document Management Systems (EDMS), Power BI, and Learning Management Systems. My expertise spans critical areas such as Process Performance Qualification, Equipment Qualification, Quality Management Systems, Quality Improvement, In-Process Quality Assurance, Annual Product Quality Reviews, and Document Management. Throughout my career, I have had the privilege of working with leading pharmaceutical companies, including Zydus Cadila, Mylan Laboratories Limited, Cipla Ltd, and Syngene International Limited. My mission is clear: to contribute to the development and delivery of safe and effective medicines that enhance the quality of life for patients and consumers. I am passionate about quality assurance and quality control, consistently seeking to expand my knowledge and skills to stay at the forefront of the field. Proficient in English, Hindi, and Kannada, I am open to new opportunities where I can leverage my QA expertise and Quality Management Systems skills in a dynamic and rewarding environment. Let’s connect to explore how my background and skills can contribute to achieving excellence in quality assurance and regulatory compliance.
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Canada
Pharmaceuticals
Compliance walk, Cross functional training, Global scale of English 83/90, Ethical Decision Making, Packaging Record Review, Sampling, Attention to Detail, Solabs, JDE Enterprise One, Minitab, Document Management Systems (DMS), Microsoft Power BI, TrackWise, SAP Products, Technical Writing, Internal Audits, OOS, Analytical Skills, Research Skills, Project Management
Experience

Manufacturing Quality Assurance Associate-1
Ontario, Canada
• Conducted periodic compliance walks to ensure adherence to quality standards on the manufacturing floor. • Reviewed and approved incoming raw materials, ensuring only the highest quality inputs were utilized. • Engaged in cross-functional training to enhance team collaboration and operational efficiency. • Managed electronic batch record reviews and change control processes using QMS TrackWise.

Manufacturing Quality Assurance Associate
Etobicoke, Ontario, Canada
• Ensured compliance of cosmetic products with internal and regulatory standards through rigorous quality checks. • Conducted periodic sample collection and submission to maintain product integrity. • Prepared and issued packaging records while reviewing log books and non-conformance reports. • Collaborated with cross-functional teams at DECIEM, a dynamic startup known for innovative beauty solutions.

Quality Assurance Specialist
Brockville, Ontario, Canada
• Led investigations into deviations and market complaints, ensuring compliance with quality standards. • Managed the Quality Management System, focusing on Change Control and CAPA processes. • Reviewed and updated Standard Operating Procedures and Stability Study protocols to enhance operational efficiency. • Conducted cross-functional training and compliance walks to foster a culture of quality within Trillium Health Care Products.

Junior Manager
Mangaluru, Karnataka, India
• Served as Site Lead for Quality Management System, ensuring compliance with industry standards. • Conducted thorough reviews of equipment qualification records as part of Engineering Quality Assurance. • Led internal audits as the Lead Quality Auditor, enhancing operational efficiency and adherence to quality metrics. • Facilitated GMP training for cross-functional teams, promoting a culture of quality and compliance across the organization.

Senior Executive
Mangalore, Karnataka
• Oversaw the Quality Management System for reviewing change control and deviation records, ensuring compliance with industry standards. • Managed the issuance and retrieval of critical documents to maintain operational efficiency. • Conducted line clearance and in-process checks periodically to uphold product quality. • Performed compliance walks and reviewed equipment breakdowns and calibration records to enhance reliability.

Senior Executive
Bengaluru Area, India
• Served as the Subject Matter Expert for Process Performance Qualification and Continuous Process Verification at Mylan Laboratories Limited. • Conducted thorough reviews and approvals of all equipment qualification records to ensure compliance and operational excellence. • Reviewed batch manufacturing and packing records, facilitating the timely release of semi-finished products and finished goods. • Analyzed environmental management system trends to support sustainable practices within the organization.

Senior Associate
Bengaluru Area, India
• Oversaw process quality assurance on the shop floor, ensuring compliance with industry standards. • Made critical quality decisions to address site-specific issues, enhancing operational efficiency. • Managed the issuance of raw and packaging materials, streamlining production workflows. • Provided line clearance for batch manufacturing and packaging, ensuring product integrity and safety.

QA Officer
Verna, Goa
• Managed shop floor quality assurance activities, ensuring compliance with industry standards. • Conducted line clearance and in-process checks to maintain product integrity. • Served as a subject matter expert for the preparation and review of annual product quality reports for sterile products. • Reviewed batch manufacturing and packaging records for all finished products, ensuring accuracy and compliance.

Junior Officer- Quality assurance (IPQA) Tablet Department
Verna, Goa
• Conducted in-process activities and line clearances to ensure compliance with quality standards in the Tablet Department. • Performed sampling for packed products and stability batches, contributing to the overall quality assurance process. • Reviewed patch manufacturing and packaging records, identifying potential quality issues during compliance walks. • Collaborated with cross-functional teams at Indoco Remedies Ltd, a leading pharmaceutical company in Goa, to uphold product integrity.

Management Trainee- Quality Assurance
Kundaim, Goa
• Conducted IPQA for sterile dose products, ensuring compliance with quality standards. • Managed NVPC trending and batch record reviews to maintain product integrity. • Executed sampling activities for routine batch and process validation, enhancing operational efficiency. • Facilitated line clearance activities for manufacturing and batch packaging processes.
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