job description
Join IOI Acidchem Sdn Bhd as a Senior Quality Systems Executive and play a pivotal role in ensuring the highest standards of quality in pharmaceutical and medical device manufacturing. This is a unique opportunity to lead quality assurance initiatives in a dynamic and innovative environment, contributing to products that impact global healthcare.
Based in the vibrant regions of Bali, including Canggu, Ubud, and Denpasar, this role offers a blend of professional growth and an exceptional work-life balance. You will collaborate with cross-functional teams to implement and maintain robust quality management systems, ensuring compliance with international regulations and industry best practices.
If you are passionate about quality excellence and eager to make a difference in the healthcare sector, we invite you to apply and become part of our mission to deliver safe, effective, and high-quality products to patients worldwide.
Responsibility
- Develop, implement, and maintain quality management systems (QMS) in accordance with ISO 13485, GMP, and other relevant regulatory standards.
- Lead internal and external audits to ensure compliance with quality systems and regulatory requirements.
- Oversee the documentation and control of quality records, including SOPs, batch records, and deviation reports.
- Collaborate with R&D, production, and supply chain teams to ensure quality standards are integrated into all stages of product development and manufacturing.
- Investigate and resolve quality-related issues, implementing corrective and preventive actions (CAPA) to mitigate risks.
- Provide training and guidance to staff on quality systems, regulatory requirements, and best practices.
- Monitor industry trends and regulatory updates to ensure continuous improvement of quality systems.
- Represent the company in interactions with regulatory authorities and external auditors.
Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biomedical Engineering, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in quality assurance or quality systems within the pharmaceutical or medical device industry.
- In-depth knowledge of regulatory standards such as ISO 13485, GMP, FDA, and EU MDR.
- Proven experience in leading audits, managing CAPA processes, and maintaining QMS documentation.
- Strong analytical and problem-solving skills with a keen attention to detail.
- Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams.
- Certification in quality management (e.g., ASQ, IRCA) is a plus.
- Ability to work independently and manage multiple priorities in a fast-paced environment.