Deskripsi pekerjaan
ME Compliance Staff bertanggung jawab untuk memastikan bahwa seluruh aktivitas terkait Mechanical Engineering (ME) dan EHS (Environment, Health, and Safety) mematuhi standar cGMP serta regulasi yang berlaku. Peran ini mencakup dukungan terhadap dokumentasi kepatuhan, implementasi CAPA, manajemen SOP, dan aktivitas kualitas lainnya di sepanjang proyek fasilitas farmasi. Kandidat akan berperan dalam meninjau dan menilai aktivitas ME-EHS, mengembangkan serta merevisi SOP, serta menyiapkan laporan yang diperlukan untuk implementasi dan penutupan CAPA. Posisi ini membutuhkan pemahaman mendalam tentang sistem kualitas farmasi dan kemampuan komunikasi yang baik dalam bahasa Inggris.
Tanggung jawab: Review and assess ME and EHS activities to ensure compliance with cGMP, applicable regulations, and company requirements; Review, develop, and revise ME-EHS SOPs and related documents; Prepare and maintain reports, documentation, and supporting records required for CAPA implementation and closure; Support compliance-related activities and documentation throughout the pharmaceutical facility development project; Perform other compliance-related activities or tasks as assigned.
Kualifikasi: Bachelor's Degree in Pharmacy or related field; Minimum 2 years of experience in the pharmaceutical industry; Good understanding of cGMP requirements and pharmaceutical quality systems; Understanding of Good Distribution Practice (GDP) and pharmaceutical facility requirements; Good understanding of pharmaceutical manufacturing and facility-related activities; Proficient in Microsoft Office; Good command of English, both verbal and written.
Tanggung jawab
- Review and assess ME and EHS activities to ensure compliance with cGMP, applicable regulations, and company requirements
- Review, develop, and revise ME-EHS SOPs and related documents
- Prepare and maintain reports, documentation, and supporting records required for CAPA implementation and closure
- Support compliance-related activities and documentation throughout the pharmaceutical facility development project
- Perform other compliance-related activities or tasks as assigned
Kualifikasi
- Bachelor's Degree in Pharmacy or related field
- Minimum 2 years of experience in the pharmaceutical industry
- Good understanding of cGMP requirements and pharmaceutical quality systems
- Understanding of Good Distribution Practice (GDP) and pharmaceutical facility requirements
- Good understanding of pharmaceutical manufacturing and facility-related activities
- Proficient in Microsoft Office
- Good command of English, both verbal and written
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Pendidikan
- S1
- Gaji
- Negosiasi