CV Profile No.99686

Experience in the following industries :

• Chemistry, petrochemistry, raw materials, mining
• Health, pharmacy, hospitals, medical equipment
• Paper, wood, rubber, plastic, glass, tobacco
• Pharmaceutical industry
• Quality, methods

Professional experience

• Quality Assurance Manager
• Plus Five Pharmaceuticals
• Since 11.2022
• Oversee batch release and control of manufacturing test documentation, ensuring compliance with regulatory standards. - Develop and monitor the Quality Management System (QMS), emphasizing critical quality parameters for continual improvement. - Coordinate, prepare, execute, and follow up on inspections (CAPAs) by regulatory bodies and supplier audits. - Lead the investigation and resolution of customer complaints, maintaining high-quality service standards. - Establish and manage the Pharmacovigilance system to ensure product safety and compliance. - Organize and execute GMP training, overseeing planning, implementation, and success tracking. - Validate and qualify processes, ensuring alignment with the Validation Master Plan and compliance standards. - Supervise Quality Control and Validation functions to maintain operational efficiency. - Ensure cGMP and regulatory compliance for marketing and manufacturing authorization. - Conduct routine internal audits and regulatory quality audits, developing relevant CAPAs. - Review and approve Standard Operating Procedures (SOPs), validation reports, and quality manuals. - Plan resources, including financial, personnel, and capital expenditure budgets for QA and QC departments.

• Quality Control Manager
• Plus Five Pharmaceuticals
• 05.2020 - 11.2022
• - Develop departmental SOPs and review interdepartmental procedures for enhanced efficiency. - Uphold the integrity of Quality Management Systems/Processes, offering solutions for improvement. - Approve or reject analytical results for starting materials, intermediates, and finished products. - Review Batch Manufacturing Records to ensure compliance with standards. - Enforce strict adherence to Good Manufacturing Practices (GMP) during manufacturing activities. - Manage out-of-specification results and participate in Quality Risk Assessments. - Investigate complaints and represent the department in internal and external audits. - Oversee quality control activities during Technology Transfer at the site. - Audit and qualify raw material and packaging suppliers - Participate in Change Control assessments to maintain compliant equipment status. - Conduct training on good manufacturing practices for personnel

• Laboratory Manager
• Plus Five Pharmaceuticals
• 05.2018 - 04.2020
• Implement and enforce Good Laboratory Practices (GLP) for operational excellence. - Ensure laboratory safety and compliance with health, safety, and environmental regulations. - Review analytical reports for various materials and draft SOPs for equipment and safety. - Manage real-time stability plans and equipment calibration schedules. - Facilitate technology transfer from Research and Development to production. - Handle inventory for laboratory reagents and consumables, ensuring adequacy. - Train laboratory staff on equipment use, safety protocols, and GLP standards

• Quality Control Chemist
• Plus Five Pharmaceuticals
• 11.2016 - 04.2018
• Conduct in-process quality control in wet and dry plant environments. - Sample raw materials and packaging materials for quality assessment. - Analyze raw materials, finished products, and real-time stability samples. - Perform instrument calibrations and assist in investigating out-of-specification results. - Contribute to investigations of customer complaints.