Senior Quality Systems Executive (Pharmaceutical & Medical Devices)

IOI Acidchem Sdn Bhd · 📍 Canggu,Ubud,Denpasar,Jimbaran,Nusa Dua,Kuta,Badung · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
IDR 15000000 - 25000000
IOI Acidchem Sdn Bhd is seeking a highly skilled and experienced Senior Quality Systems Executive to join our team. In this role, you will be responsible for ensuring the quality and compliance of our pharmaceutical and medical devices products. You will work closely with cross-functional teams to implement and maintain quality systems that meet international standards. This is an exciting opportunity to contribute to a company that is at the forefront of the pharmaceutical and medical devices industry.

📋 Tanggung Jawab Pekerjaan

Develop, implement, and maintain quality systems and procedures for pharmaceutical and medical devices products.,Ensure compliance with international quality standards, including ISO 13485 and FDA regulations.,Lead and mentor quality teams to achieve and maintain high-quality standards.,Conduct audits and inspections to verify compliance with quality systems and procedures.,Identify and mitigate quality risks to ensure product safety and efficacy.,Collaborate with regulatory affairs, production, and other departments to ensure quality throughout the product lifecycle.,Provide training and support to employees on quality systems and procedures.,Monitor and analyze quality data to identify trends and areas for improvement.

🎓 Kualifikasi & Syarat

Bachelor's degree in Pharmacy, Chemistry, or a related field.,Minimum of 8 years of experience in quality systems for pharmaceutical and medical devices.,Strong understanding of international quality standards, including ISO 13485 and FDA regulations.,Proven experience in leading and mentoring quality teams.,Excellent communication and interpersonal skills.,Ability to work independently and as part of a team.,Strong analytical and problem-solving skills.,Proficiency in English, both written and spoken.

🛠️ Keahlian

Quality Systems ManagementRegulatory AffairsProcess ValidationRisk ManagementData AnalysisTraining and DevelopmentProject ManagementCompliance Management
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