
Commercial Quality Professional
7 days ago
We are seeking a highly skilled and experienced Quality Manager to join our team. As a key member of our organization, you will be responsible for ensuring the commercial quality of our products in Singapore, Vietnam, and Malaysia.
Main Responsibilities:
• Quality Oversight: Ensure that our products meet the highest quality standards by conducting regular audits and implementing corrective actions as needed.
• Regulatory Compliance: Ensure that our operations comply with all relevant laws and regulations in the country.
• Supplier Management: Manage our local suppliers, manufacturers, and distributors to ensure they meet our quality requirements.
• Market Release: Oversee the market release of our products from approved suppliers based on batch release documentation and transport conditions documentation.
• Distribution: Ensure the GDP compliance of our distribution centers and maintain accurate records of product distribution and returns.
• Complaints and Recalls: Investigate quality complaints and initiate recalls when necessary, working closely with our pharmacovigilance department and other stakeholders.
• Change Control: Administer and maintain systems for change control, deviation, and CAPA handling.
• SUPPLIER MANAGEMENT: Maintain, monitor, and approve lists of approved third parties.
• Archiving: Ensure that relevant quality-related documentation is archived as required.
• Critical Quality Incidents: Report critical quality incidents to management and regional/corporate quality teams.
Qualifications & Experience:
• Education: Degree in Pharmaceutical Sciences, Business, Healthcare, or an equivalent combination of education and experience to the functional role.
• Experience: Minimum of 2-4 years of experience as a Quality Manager/QP in a pharmaceutical company or importer/distributor.
• Skills: Demonstrated knowledge and working experience with PIC/S GMP and GDP and government regulations for the country, in-depth knowledge of pharmaceutical industry as it relates to Quality Compliance, working knowledge of pharmaceutical import and distribution operations, commercial understanding of corporate and operational business issues, fluent written and spoken English, ability to clearly communicate with all levels in the organization and health authorities, excellent interpersonal skills to interface directly with management, sites, commercial, and distributors, strong analytical, planning, and strategic thinking skills, self-starter with hands-on approach, strong 'can do' attitude, openness to change, global mindset, experience working in a global multi-national pharmaceutical company, and proficient computer skills including MS Office.
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