Deskripsi Pekerjaan
Join Kalbio Global Medika as a Computerized System Validation Officer and play a pivotal role in safeguarding the integrity and compliance of our pharmaceutical systems. This position offers a unique opportunity to work at the intersection of technology and regulatory excellence in Indonesia's growing healthcare sector. You will develop, implement, and maintain robust validation procedures ensuring all computerized systems meet stringent industry standards. Your expertise will directly impact product quality by ensuring data integrity, traceability, and audit readiness. This role requires a detail-oriented professional passionate about quality assurance and regulatory compliance. If you thrive in environments where precision meets innovation, Kalbio Global Medika provides the platform to advance your career while contributing to life-saving pharmaceutical solutions.
Tanggung Jawab
- Develop and execute validation protocols for computerized systems in compliance with cGMP, FDA, and local regulations
- Conduct risk assessments and validation activities for pharmaceutical manufacturing and laboratory systems
- Maintain and update validation documentation including validation plans, protocols, and final reports
- Ensure data integrity through rigorous testing, verification, and ongoing monitoring of system performance
- Collaborate with cross-functional teams to implement validation requirements for new and existing systems
- Investigate and resolve validation discrepancies and non-conformances with CAPA implementation
- Stay current with evolving regulatory guidelines and industry best practices in computerized system validation
Kualifikasi
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific field
- Minimum 3 years' experience in computerized system validation within pharmaceutical or healthcare industry
- Strong knowledge of GMP principles, data integrity guidelines, and regulatory requirements
- Proficiency in validation methodologies and risk assessment tools (e.g., FMEA, HACCP)
- Experience with pharmaceutical industry-specific systems (LIMS, ERP, MES)
- Excellent documentation skills with attention to detail and accuracy
- Strong analytical and problem-solving abilities with excellent communication skills