Apoteker Penanggung Jawab

Apoteker Penanggung Jawab

Job Summary
Responsible for leading and ensuring regulatory compliance across manufacturing operations. This role oversees the implementation of Quality Management Systems (QMS), product release, validation, internal and external audits, and regulatory communications while ensuring compliance with BPOM, CPOTB, GMP, and Halal requirements.

Key Responsibilities

• Quality Assurance & Regulatory Compliance: Lead and oversee Quality Assurance activities, ensuring manufacturing, packaging, and distribution processes comply with CPOTB, GMP, BPOM, and Halal regulations while maintaining an effective Quality Management System (QMS).
• Quality System & Documentation Management: Develop, review, approve, and maintain quality documents, including SOPs, Master Production Records (MPR), Batch Records, specifications, change control, CAPA, and document control systems.
• Validation, Product Release & Quality Investigation: Manage process, equipment, facility, and system validation, approve finished product release based on Quality Control results, investigate deviations, complaints, and non-conformities, and implement effective CAPA and Root Cause Analysis (RCA).
• Audit & Regulatory Affairs: Lead internal audits, supplier audits, and external inspections (BPOM, Halal Certification, ISO, customers), ensuring audit readiness, regulatory compliance, and timely closure of audit findings.
• Cross-Functional Collaboration & Stakeholder Management: Collaborate closely with Production, QC, Regulatory Affairs, Engineering, and external authorities to ensure product quality, regulatory compliance, and continuous improvement across manufacturing operations.
• People Development & Quality Culture: Lead, coach, and develop the Quality Assurance team while promoting a strong quality culture through GMP, CPOTB, hygiene, safety, and compliance training across the organization.

Qualifications

• Bachelor's Degree in Pharmacy with a Professional Pharmacist License (Apoteker).
• Active STRA (Pharmacist Registration Certificate) and SIPA (Pharmacist Practice License), or willing to process SIPA based on placement requirements.
• Minimum 3–5 years of experience in Quality Assurance, Quality Management, or as a Responsible Pharmacist within the pharmaceutical, herbal, traditional medicine, or cosmetics industry.
• Strong knowledge of CPOTB, GMP, CPOB, BPOM regulations, HACCP, ISO 9001, ISO 22000, CAPA, validation, and quality risk management.
• Experienced in internal and external audits, quality documentation, validation, and product release processes.
• Strong leadership, analytical thinking, problem-solving, communication, and stakeholder management skills.
• Willing to work on-site in Yogyakarta.