Roles & Responsibilities : -
Quality Management and Control:
• Assist professional consultant with HSA and medical-licensing-related matters and establish the operation system during the initial setup period.
• Oversee the entire packaging workshop, including specific data coding, laser printing, and cellophane wrapping of finished products.
• Manage the entire product packaging process, including the inspection of finished products and packaging materials.
• Fully responsible for Inspections and Approval of all packaging materials, comprising starting intermediate, bulk, and finished products, to align with our premium standards and high-quality specifications.
• Ensure all relevant testing are conducted and records are evaluated.
• Approve specifications, sampling instructions, test methods, and other Quality Control procedures.
• Responsible for ensuring top notch maintenance of the factory premises, and production equipment.
• Participate in internal facility inspections (internal audits) to evaluate and improve site quality systems.
• Maintain written and signed records of all audits and inspections, reporting to management as required.
• Investigate non-conformance using 8D principles of root cause analysis to deliver effective solutions via the corrective action reporting process.
• Communicate with other teams, departments, and stakeholders to align quality control processes with business objectives.
• Develop, implement & review SOPs, protocols/batch records, reports, quality and regulated records for accuracy and compliance with regulations and internal policies.
• Ensure appropriate validations are performed.
• Ensure proper initial and regular training of department personnel is being conducted and adapted as required.
• Oversee and monitor the overall Quality Management System to ensure production meets the highest standards.
• Manage and maintain quality control documentation, ensuring all necessary records and reports are accurate and up-to-date.
• Assist consultants in training operational personnel regarding basic regulatory requirements.
Knowledge/Skill Requirements:
• Candidate must possess at least bachelor's degree / Master Degree or higher in Chemistry/ Pharmaceuticals or equivalent in a relevant field.
• Strong leadership skills with the ability to motivate and inspire team members to achieve business objectives.
• Competent and highly motivated to Head and Manage the Quality Control and assurance team.
• In-depth knowledge of GMP and other relevant industry standards and regulations.
• Excellent analytical skills with the ability to analyse data and identify trends.
• Strong communication skills, effective with team members and stakeholders at all levels.
• Attention to detail and ability to identify and resolve issues quickly and effectively.
• Strong problem-solving skills with the ability to think creatively and develop innovative solutions.
• Excellent organizational skills, capable of managing multiple tasks and priorities simultaneously.
• Extensive knowledge of quality control processes, procedures, and policies.
· Proficiency in Microsoft Office Suite and other relevant software applications.
• Minimally 6 years to 10 years of experience in Quality Control within the manufacturing industry.
Expected High Performance Behaviours:
• Exhibit a positive attitude regarding work and responsibilities.
• Ability to work collaboratively within a team.
• Maintain effectiveness during significant changes in work tasks or environment, adjusting effectively to new work structures, processes, requirements, or cultures.
• Consistently seeking to enhance efficiency and improve quality standards.
