job description
Join MSD, a global leader in pharmaceutical innovation, as a Digital & Data Quality (DDQ) Site Operations Specialist in the vibrant region of Badung, Bali. This is a unique opportunity to leverage your GxP expertise to drive digital transformation and ensure data integrity across our manufacturing and logistics operations.
In this critical role, you will play a pivotal part in enhancing operational efficiency, compliance, and data-driven decision-making for one of the worldâs most respected healthcare companies. Your work will directly impact the quality and reliability of life-saving medications, ensuring they meet the highest regulatory and industry standards.
Based in Baliâs dynamic business hub, youâll collaborate with cross-functional teams to implement cutting-edge digital solutions, streamline processes, and maintain rigorous data quality standards. Whether youâre optimizing manufacturing workflows or ensuring seamless logistics operations, your contributions will help shape the future of pharmaceutical excellence.
Responsibility
- Lead the implementation and maintenance of digital quality systems to ensure compliance with GxP, FDA, and ICH regulations.
- Develop and enforce data integrity policies and procedures for manufacturing, transport, and logistics operations.
- Collaborate with IT and operational teams to integrate data-driven solutions that enhance efficiency and accuracy.
- Conduct regular audits and risk assessments to identify and mitigate data quality gaps.
- Train and mentor staff on best practices in digital compliance and data management.
- Monitor and analyze KPIs and performance metrics to drive continuous improvement in site operations.
- Ensure seamless documentation and reporting for regulatory inspections and internal reviews.
- Support the deployment of emerging technologies (e.g., IoT, AI, automation) to optimize pharmaceutical processes.
Qualifications
- Bachelorâs degree in Pharmacy, Chemical Engineering, Computer Science, or a related field. Advanced degrees preferred.
- Minimum 5 years of experience in GxP-compliant environments, preferably in pharmaceutical manufacturing or logistics.
- Proven expertise in data integrity, digital transformation, and quality management systems (QMS).
- Strong knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, ICH Q7).
- Experience with ERP, MES, or LIMS systems and data analytics tools.
- Excellent problem-solving, communication, and stakeholder management skills.
- Certifications in Six Sigma, Lean Manufacturing, or Project Management (PMP) are a plus.
- Fluency in English; proficiency in Indonesian is advantageous.