job description
Join a leading pharmaceutical organization in Bali as a Quality Assurance Specialist, where your expertise will directly impact patient safety and product integrity. This role offers a unique opportunity to advance your career in a dynamic, compliance-driven environment with competitive benefits, professional development programs, and a collaborative work culture.
In this position, you will play a pivotal role in ensuring that all pharmaceutical products meet stringent regulatory standards (e.g., FDA, WHO, GMP) while contributing to continuous improvement initiatives. Based in the vibrant regions of Canggu, Ubud, Denpasar, or surrounding Bali areas, you’ll work alongside industry experts to uphold the highest quality benchmarks in the healthcare sector.
If you are passionate about quality control, regulatory compliance, and making a tangible difference in public health, this is your chance to thrive in a role that values precision, innovation, and excellence.
Responsibility
- Develop, implement, and maintain Quality Assurance (QA) systems and Standard Operating Procedures (SOPs) in compliance with local and international regulations (e.g., GMP, ISO, FDA).
- Conduct thorough audits of manufacturing processes, documentation, and facilities to ensure adherence to quality standards.
- Investigate and resolve quality-related deviations, non-conformances, and customer complaints with root cause analysis (RCA) and corrective/preventive actions (CAPA).
- Collaborate with cross-functional teams (Production, R&D, Regulatory Affairs) to ensure product quality from raw material to final release.
- Review and approve batch records, test results, and validation documents to guarantee compliance before product distribution.
- Monitor industry trends and regulatory updates to proactively adjust QA policies and training programs.
- Prepare and submit regulatory filings, inspections, and certifications to authorities (e.g., BPOM, WHO).
- Lead continuous improvement initiatives to enhance efficiency, reduce risks, and optimize quality control processes.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, or related life sciences; Master’s degree is a plus.
- Minimum 3–5 years of experience in Quality Assurance within the pharmaceutical, biotech, or medical device industry.
- In-depth knowledge of GMP, GLP, ISO 9001, ICH guidelines, and other relevant regulatory frameworks.
- Proven experience with audit management, CAPA systems, and risk assessment tools (e.g., FMEA).
- Strong analytical, problem-solving, and documentation skills with attention to detail.
- Excellent communication skills in English (written and verbal) for reports, training, and stakeholder interactions.
- Proficiency in QA software (e.g., TrackWise, MasterControl) and Microsoft Office Suite.
- Certifications in Six Sigma, Lean, or QA/RA are highly advantageous.