QA (Qualification & Validation) Supervisor
SKPlasma Core Indonesia · KARAWANG, JAWA BARAT, ID
Sekilas tentang pekerjaan ini
QA (Qualification & Validation) Supervisor di SKPlasma Core Indonesia bertanggung jawab mengawasi kualifikasi dan validasi fasilitas, utilitas, peralatan, proses, serta sistem komputerisasi untuk mendukung manufaktur farmasi yang memenuhi GMP. Posisi ini berlokasi di Karawang, Jawa Barat.
Tugas utama
- Mengawasi DQ, IQ, OQ, dan PQ untuk fasilitas, utilitas, serta peralatan produksi.
- Mengawasi validasi proses, pembersihan, batch, media fill, dan sistem komputerisasi.
- Meninjau protokol, data mentah, dan laporan validasi sebelum diajukan kepada QA2 Manager.
- Mengoordinasikan kegiatan kualifikasi dan validasi dengan tim terkait serta vendor eksternal.
- Membimbing QA2 Specialists dan Staff serta mendukung audit dan inspeksi regulasi.
Ringkasan ini dibuat dengan AI dari deskripsi di bawah. Yang berlaku adalah deskripsi lengkapnya di situs SKPlasma Core Indonesia.
Deskripsi pekerjaan
Role Purpose
To supervise and ensure effective execution of qualification and validation activities for facilities, utilities, equipment, processes, and computerized systems, ensuring GMP compliance and readiness to support pharmaceutical manufacturing operations.
Role Description
- Supervise execution of DQ, IQ, OQ, and PQ activities for production equipment, utilities, and facilities in accordance with approved protocols and GMP requirements.
- Supervise process validation, cleaning validation, batch validation, and related lifecycle validation activities.
- Coordinate and supervise media fill and aseptic validation activities together with Production and QA1 (QMS & GMP Compliance).
- Supervise execution of Computer System Validation (CSV) activities for GMP‑relevant computerized systems in coordination with IT and Engineering.
- Review validation protocols, raw data, and reports for completeness, accuracy, and compliance before submission to QA2 Manager.
- Ensure proper handling and documentation of deviations, discrepancies, and changes related to qualification and validation activities.
- Coordinate daily qualification and validation activities with Production, Engineering, QA1, QC, and external vendors.
- Support internal audits, external audits, and regulatory inspections related to qualification and validation.
- Supervise and guide QA2 Specialists and Staff, including task assignment, monitoring progress, and on‑the‑job coaching.
- Ensure qualification and validation activities are executed on schedule without compromising GMP compliance.
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