Deskripsi pekerjaan
PT. Daewoong Pharmaceutical Indonesia mencari Quality Assurance Validation Supervisor yang akan ditempatkan di Cikarang Timur, Jawa Barat. Peran ini sangat krusial dalam memastikan standar kualitas dan kepatuhan tertinggi dalam operasional farmasi perusahaan. Sebagai Validation Supervisor, Anda akan memimpin tim profesional QA, mengawasi aktivitas validasi, serta memastikan seluruh proses, sistem, dan peralatan memenuhi persyaratan regulasi yang ketat. Tanggung jawab mencakup penyusunan Validation Master Plan (VMP), pelaksanaan kualifikasi, kalibrasi, serta validasi proses untuk menjaga integritas produk dan reputasi keunggulan perusahaan.
Tanggung jawab: Prepare and implement Validation Master Plan (VMP) and its schedules.; Supervise and/or carry out all calibration, qualification, and validation runs.; Implement Right-First-Time (RFT) principles to all calibration, qualification, and validation jobs.; Prepare and/or review standard operating procedures and work instructions.; Prepare process validation and cleaning validation protocols, reports, and raw data.; Prepare qualification protocols, reports, and raw data including temperature mapping.; Prepare internal and external calibration documentation.; Prepare transportation verification protocols and reports.; Execute computerized system validation protocols.; Provide training related to calibration, qualification, and validation jobs to validation inspectors.; Utilize, maintain, and store Quality Assurance Department documents and assets..
Tanggung jawab
- Prepare and implement Validation Master Plan (VMP) and its schedules.
- Supervise and/or carry out all calibration, qualification, and validation runs.
- Implement Right-First-Time (RFT) principles to all calibration, qualification, and validation jobs.
- Prepare and/or review standard operating procedures and work instructions.
- Prepare process validation and cleaning validation protocols, reports, and raw data.
- Prepare qualification protocols, reports, and raw data including temperature mapping.
- Prepare internal and external calibration documentation.
- Prepare transportation verification protocols and reports.
- Execute computerized system validation protocols.
- Provide training related to calibration, qualification, and validation jobs to validation inspectors.
- Utilize, maintain, and store Quality Assurance Department documents and assets.
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Gaji
- Negosiasi