QA (QMS & GMP Compliance) Specialist
SKPlasma Core Indonesia · KARAWANG, JAWA BARAT, ID
Sekilas tentang pekerjaan ini
QA (QMS & GMP Compliance) Specialist di SKPlasma Core Indonesia bertanggung jawab mengelola dan meningkatkan QMS serta kepatuhan GMP untuk mendukung manufaktur farmasi yang memenuhi persyaratan regulasi. Posisi ini berlokasi di Karawang, Jawa Barat.
Tugas utama
- Mengoperasikan dan memelihara QMS sesuai GMP dan persyaratan regulasi.
- Mengelola dokumen mutu, termasuk SOP, spesifikasi produk, dan catatan bets.
- Memantau change control, deviasi, dan CAPA, termasuk tinjauan efektivitas.
- Mendukung pengelolaan pelatihan dan kualifikasi pemasok dari perspektif QMS.
- Mendukung audit, inspeksi regulator, serta dokumentasi Contamination Control Strategy.
Ringkasan ini dibuat dengan AI dari deskripsi di bawah. Yang berlaku adalah deskripsi lengkapnya di situs SKPlasma Core Indonesia.
Deskripsi pekerjaan
Role Purpose
To establish, operate, and continuously improve the Quality Management System (QMS) and GMP compliance framework by managing documentation, change control, deviation, CAPA, training systems, and supplier quality processes to ensure regulatory‑compliant pharmaceutical manufacturing operations.
Role Description
- Operate and maintain the Quality Management System (QMS) in accordance with GMP, internal policies, and regulatory requirements.
- Prepare, review, revise, and control quality documents, including SOPs, product specifications, batch records, and quality forms.
- Manage document control lifecycle, including issuance, revision, distribution, archival, and retrieval.
- Execute and monitor change control, deviation management, and CAPA processes, including documentation, tracking, and effectiveness review.
- Support training management, including training planning, scheduling, training matrix maintenance, and training record control.
- Support and execute supplier evaluation and qualification activities from a QMS perspective, including documentation review and follow‑up.
- Support internal audits, external audits, and regulatory inspections, ensuring QMS readiness and completeness of documentation.
- Support implementation and maintenance of Contamination Control Strategy (CCS) documentation and governance.
- Support technology transfer activities by ensuring QMS readiness, documentation alignment, and compliance during changes or scale‑up.
- Coordinate closely with QA, QC, Production, Engineering, and other departments to ensure consistent GMP implementation.