Computerized System Validation Officer (Pharmacy Industry)

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 pharmaceutical industry. In Cikarang Pusat, you'll be part of a dynamic team dedicated to ensuring our systems meet the highest regulatory standards, leveraging cutting-edge technology to drive innovation and efficiency.

As a Computerized System Validation Officer, you'll be responsible for validating and verifying our pharmaceutical systems to ensure they comply with Good Manufacturing Practice (GMP) and Good Automated Manufacturing Practice (GAMP) guidelines. You'll work closely with cross-functional teams to implement and maintain robust validation processes, using tools like Oracle and SAP. This role is perfect for professionals with a strong background in pharmaceutical technology and a passion for regulatory compliance.

📋 Tanggung Jawab Pekerjaan

• Conduct validation activities for pharmaceutical systems to ensure compliance with GMP and GAMP guidelines.
• Develop and maintain validation protocols and procedures.
• Perform system verification and validation testing using Oracle and SAP.
• Collaborate with cross-functional teams to implement and maintain robust validation processes.
• Document validation activities and maintain validation records.
• Ensure compliance with regulatory requirements and industry standards.
• Provide training and support to staff on validation processes.
• Stay updated with industry trends and regulatory changes.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmaceutical Technology, Computer Science, or a related field.
• Minimum of 3 years of experience in pharmaceutical system validation.
• Certification in GAMP or equivalent.
• Proficiency in Oracle and SAP.
• Strong understanding of GMP and GAMP guidelines.
• Excellent analytical and problem-solving skills.
• Strong communication and teamwork skills.
• Ability to work in a fast-paced, dynamic environment.

🛠️ Keahlian

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