Role and Responsibilities

• Manage all on site Quality functions (including vendors) eg quality control, quality assurance, regulatory compliance, provide quality oversight for all ISO/GMP activities on site in line with our Quality Management Systems and in compliance to applicable regulatory guidelines.

• Responsible for the development of quality control duties such as establishment, verification and implementation of all quality control procedures in respect of quality system to comply with all statutory GMP & ISO standards.

• Develop and maintain quality system to comply with GMP, GDP, SS620 ISO 9001, ISO 13485 and prevailing regulatory quality requirements.

• Responsible for management of quality control duties such as establishment, verification and implementation of all quality control procedures.

• Drive divisional and site strategies on site, build robust quality systems and quality culture.

• Undertake regulatory affairs including medical products' registration with health authorities. Facilitate communications with regulatory agencies to support required compliance and business needs

• Develop and maintain submissions to regulatory agencies to allow the company to manufacture, supply and distribute healthcare and medical products. Obtain regulatory /product registration approvals for medical products to be marketed in various territories.

• Partner with project team to develop business and organizational direction, design and execution of management strategies

• Lead, guide, develop and sustain a highly flexible and motivated business unit team to deliver quality support which are timely, cost effective, GMP and business compliant

• Develop and oversee sustainability programs, ensuring compliance with regulations, and report on progress.

• Work with key stakeholders to focus on specific areas like energy efficiency, waste management, or supply chain sustainability and involve setting goals, defining KPIs, and creating action plans to improve environmental and social performance. monitoring

Requirements

• At least bachelor's degree/Post Graduate Diploma/Professional Degree in Biotechnology, Chemistry, Science & Technology or equivalent.

• At least 5 years of working experience in a medical logistics or pharmaceutical related industry

• Working knowledge of ISO, GMP, GDP and other regulatory authorities

• Extensive experience in Quality Systems development, implementation, and training experience

• Strong experience with ISO 13485, GMP, GDP compliance requirements.

• Strong experience in Regulatory submission experience

• Proficient in using MS Excel, Words & PowerPoint

• Ability to understand broad business issues

• Problem-solving and decision-making abilities, meticulous and good analytical skills

• Planning and organization skills, good communication and presentation skills

• Results orientated, with a high level of integrity and dependability with a strong sense of urgency•

• Able to develop in-depth technical related trouble shooting skills and timely analysis

• Ability to work with different levels of stakeholders and drive projects

• Must be able to work independently and have the ability to work with cross-functional teams

Additional Notes:

Working Location: 4 Pandan Avenue, Singapore 609383

Working Hours: Monday to Thursday 8.30am to 6pm

Friday 8.30am to 5.30pm