Quality Assurance (QMS & GMP Compliance) Supervisor
SKPlasma Core Indonesia · KARAWANG, JAWA BARAT, ID
Sekilas tentang pekerjaan ini
Quality Assurance (QMS & GMP Compliance) Supervisor di SKPlasma Core Indonesia bertanggung jawab memastikan kepatuhan GMP, kesiapan regulasi, dan pengembangan sistem mutu. Posisi ini berlokasi di Karawang, Jawa Barat.
Tugas utama
- Menetapkan, menerapkan, memelihara, dan meningkatkan Quality Management System sesuai GMP.
- Mengelola SOP, spesifikasi produk, catatan batch, dokumen registrasi, dan pengendalian dokumen.
- Mengawasi change control, deviasi, CAPA, investigasi, dan pemeriksaan efektivitas.
- Menyusun rencana pelatihan GMP serta mengelola catatan dan efektivitasnya.
- Mendukung evaluasi pemasok, audit internal dan eksternal, serta koordinasi lintas fungsi.
Ringkasan ini dibuat dengan AI dari deskripsi di bawah. Yang berlaku adalah deskripsi lengkapnya di situs SKPlasma Core Indonesia.
Deskripsi pekerjaan
Role Purpose
Establish, operate, and continuously improve the Quality Management System to ensure GMP compliance, regulatory readiness, and quality culture across the organization.
Role Description
- Quality Management System (QMS)
- Establish, implement, and maintain the Quality Management System (QMS) in compliance with GMP and regulatory requirements.
- Prepare, review, and manage SOPs, product specifications, batch records, and registration‑related documents.
- Oversee document control systems, ensuring proper lifecycle management, version control, and data integrity.
- Manage change control, deviation management, and CAPA systems, including investigation oversight and effectiveness checks.
- Ensure QMS processes are effectively implemented and continuously improved.
- Training Management
- Develop and manage training plans and schedules to ensure GMP competency across departments.
- Oversee training record management, ensuring completeness, accuracy, and audit readiness.
- Monitor training effectiveness and compliance with internal and regulatory requirements.
- Supplier Evaluation & External Quality
- Support and perform supplier evaluation and qualification activities.
- Review supplier quality documentation and support supplier audits when required.
- Ensure supplier quality performance aligns with company and regulatory expectations.
- Compliance, Audit & Cross‑Functional Support
- Support internal and external audits, acting as QMS focal point when required.
- Collaborate with Production, QC, Engineering, RA, and other stakeholders to ensure effective QMS implementation.
- Support technology transfer activities from a quality system perspective.
- Support establishment and management of Contamination Control Strategy (CCS), where applicable.
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