
Quality Assurance
2 weeks ago
Key Responsibilities
- Oversee all on-site Quality functions, including vendor-related activities such as quality control, quality assurance, and regulatory compliance. Provide quality oversight for all ISO/GMP initiatives in alignment with our Quality Management System and applicable regulatory requirements.
- 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.
- Design, implement, and maintain quality systems that adhere to GMP, GDP, SS620, ISO 9001, ISO 13485, and other relevant regulatory quality standards.
- Manage all aspects of quality control operations, including procedure development, verification, and execution.
- Drive divisional and site strategies on site, build robust quality systems and quality culture.
- Handle regulatory affairs activities, including the registration of medical products with relevant health authorities and maintain communications with regulatory bodies to meet compliance and business objectives.
- 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.
- Collaborate with project teams to shape business direction and support the design and implementation of organizational strategies.
- Lead, mentor, 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 manage sustainability programs, ensuring compliance with regulations, and report on progress.
- Collaborate with key stakeholders to drive initiatives in areas such as energy efficiency, waste reduction, and sustainable supply chains. Set goals, define KPIs, and develop actionable plans to enhance environmental and social impact.
Preferred Experience and Qualifications
- Minimum of a Bachelor's Degree, Postgraduate Diploma, or Professional Qualification in Biotechnology, Chemistry, Science & Technology, or a related field.
- At least 5 years of relevant experience in the medical logistics or pharmaceutical industry.
- Sound knowledge of ISO standards, GMP, GDP, and regulatory frameworks.
- Proven track record in developing, implementing, and training in Quality Management Systems.
- In-depth understanding and experience with ISO 13485, GMP, and GDP compliance.
- Strong background in regulatory submissions and approvals.
- Proficient in Microsoft Excel, Word, and PowerPoint.
- Broad business acumen and the ability to connect quality initiatives with overall business goals.
- Strong analytical and problem-solving skills, with keen attention to detail.
- Effective planning, communication, and presentation capabilities.
- Results-driven with high integrity, dependability, and a strong sense of urgency.
- Ability to perform in-depth technical troubleshooting and deliver timely insights.
- Strong interpersonal skills to work effectively across all levels of the organization and drive cross-functional projects.
- Capable of working independently and collaboratively within multidisciplinary teams.
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