Clinical Executive - Validation & Reporting (Healthcare & Medical)

Join a dynamic healthcare team in Badung, Bali as a Clinical Executive - Validation & Reporting, where your expertise will drive the accuracy and efficiency of clinical testing, sample preparation, and reporting processes. This role is pivotal in ensuring compliance with industry standards and regulatory requirements, such as ISO 15189, GLP, and GCP. You will be part of a growing company that values innovation, integrity, and excellence in healthcare services.

As a Clinical Executive - Validation & Reporting, you will play a crucial role in maintaining the highest standards of quality and accuracy in our clinical operations. Your daily tasks will involve overseeing the validation of analytical instruments, ensuring the integrity of sample handling and storage, and generating comprehensive reports for regulatory submissions. This role offers a unique opportunity to work in a vibrant and supportive environment, contributing to the success of a company that is committed to delivering exceptional healthcare solutions.

📋 Tanggung Jawab Pekerjaan

• Oversee the validation and calibration of analytical instruments to ensure compliance with regulatory standards.
• Develop and implement standardized operating procedures (SOPs) for sample collection, preparation, and analysis.
• Conduct regular audits and inspections to maintain the integrity of clinical operations.
• Generate comprehensive reports and documentation for regulatory submissions, including ISO 15189, GLP, and GCP.
• Collaborate with cross-functional teams to ensure the accuracy and timeliness of clinical data.
• Provide training and guidance to staff on quality assurance and regulatory compliance.
• Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of clinical processes.
• Stay updated with the latest industry trends and regulatory changes to maintain compliance and drive innovation.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Clinical Laboratory Science, Biology, Chemistry, or a related field.
• Minimum of 5 years of experience in clinical validation and reporting, preferably in a healthcare or medical laboratory setting.
• Certification in ISO 15189, GLP, or GCP is a plus.
• Proficient in using laboratory information management systems (LIMS) such as LabArchives, ELN, or similar software.
• Strong knowledge of regulatory requirements and standards in the healthcare industry.
• Excellent analytical and problem-solving skills.
• Ability to work well under pressure and meet tight deadlines.
• Fluency in English and Bahasa Indonesia.

🛠️ Keahlian

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