Deskripsi pekerjaan
Kami mencari seorang Apoteker yang berdedikasi untuk mengisi posisi Junior Manager – Validation. Anda akan bertanggung jawab memimpin dan mengawasi seluruh aktivitas validasi untuk memastikan kepatuhan terhadap standar GMP/CPOB, regulasi farmasi yang berlaku, serta standar kualitas perusahaan. Peran ini memberikan arahan teknis dan kepemimpinan dalam berbagai program validasi, termasuk Computerized System Validation (CSV), Process Validation, Cleaning Validation, serta kualifikasi fasilitas dan peralatan. Anda juga akan mendukung audit GMP, tindak lanjut CAPA, serta inisiatif perbaikan berkelanjutan sambil mengembangkan performa tim validasi.
Kualifikasi: Must be a Licensed Pharmacist (Apoteker); Minimum 7 years of experience in Validation within the pharmaceutical industry, or minimum 2 years of experience as Validation Supervisor; Strong knowledge and hands-on experience in Good Manufacturing Practices (GMP/CPOB) and applicable pharmaceutical regulations.; Experienced in GMP audits, including audit preparation, participation, response to audit findings, and CAPA follow-up.; Proven experience in Computerized System Validation (CSV), including validation planning, risk assessment, documentation, and execution.; Good understanding of process validation, cleaning validation, equipment/facility qualification, and other applicable validation activities.; Strong leadership and people management skills, including coaching, delegation, performance evaluation, and competency development.; Strong analytical, problem-solving, communication, and coordination skills.; Detail-oriented, organized, and committed to quality, compliance, and continuous improvement.; Willing to be based in Cikarang..
Kualifikasi
- Must be a Licensed Pharmacist (Apoteker)
- Minimum 7 years of experience in Validation within the pharmaceutical industry, or minimum 2 years of experience as Validation Supervisor
- Strong knowledge and hands-on experience in Good Manufacturing Practices (GMP/CPOB) and applicable pharmaceutical regulations.
- Experienced in GMP audits, including audit preparation, participation, response to audit findings, and CAPA follow-up.
- Proven experience in Computerized System Validation (CSV), including validation planning, risk assessment, documentation, and execution.
- Good understanding of process validation, cleaning validation, equipment/facility qualification, and other applicable validation activities.
- Strong leadership and people management skills, including coaching, delegation, performance evaluation, and competency development.
- Strong analytical, problem-solving, communication, and coordination skills.
- Detail-oriented, organized, and committed to quality, compliance, and continuous improvement.
- Willing to be based in Cikarang.
Informasi lowongan
- Tipe pekerjaan
- Full-time
- Pendidikan
- S1
- Gaji
- Negosiasi