Job Purpose

Manage pharmaceutical production at the Pharma Factory to ensure products meet quality specifications and cGMP requirements within the required timelines and budget.

Key Responsibilities

Production Operations & Planning

• Oversee material receipt, processing, packaging, storage and finished-product transfer to ensure compliance with approved procedures and quality standards.
• Coordinate production planning with Supply Chain and provide technical and administrative direction for production activities.

Production Documentation & Control

• Prepare, review and sign production SOPs, Work Instructions and batch records; coordinate QA authorization and ensure proper implementation.
• Review and approve packaging plans, purchase requisitions, layouts, artwork, Packing Direction Records and shift schedules within the assigned authority.

Quality Assurance & Regulatory Compliance

• Collaborate with QA, QC and R&D to maintain product quality, investigate production failures and implement corrective and preventive actions.
• Ensure equipment qualification and process validation; review preventive maintenance plans and water-system qualification.
• Review and approve Change Controls, NCRs and deviations within the assigned authority.
• Participate in CPOB inspections, implement improvements and submit quarterly reports to BPOM and the Ministry of Health.

People Management & Development

• Lead, train and develop production personnel; conduct annual performance evaluations.
• Approve overtime, leave and administrative requests in line with HR policies.

Budget Management & Reporting

• Prepare the annual production budget and implement cost-efficiency initiatives.
• Submit monthly production reports on schedule.

Requirements

Education

• Bachelor’s degree in Pharmacy.
• Registered Pharmacist.

Experience

• More than 5 years of experience in the pharmaceutical industry, with hands-on knowledge of drug manufacturing, production equipment, formulation, processing and packaging.
• Knowledge of production planning, scheduling, process optimization, process control and automation.
• Strong understanding of CPOB/GMP requirements, production documentation, regulatory inspections and audit preparation.
• Knowledge of equipment qualification, validation, IPQC, QbD, deviation management, root cause investigation and CAPA.
• Understanding pharmacovigilance, HSE, ISO 9001 and Halal Product Assurance.

Skills

• Leadership & Team Development
• Communication & Interpersonal Skills
• Problem-solving & Critical Thinking
• Planning, Time & Project Management
• Data Analysis, Reporting & Budget Management