Sobre a Função
Role Objective
We are seeking a detail-oriented and technically proficient Production Officer to join our sterile injectable manufacturing team. The successful candidate will oversee the daily manufacturing processes, ensuring all operations comply with cGMP guidelines and safety protocols to produce high-quality injectable products.
Key Responsibilities
Operational Oversight: Supervise the manufacturing and filling process of sterile ampoules and vials, ensuring adherence to Batch Manufacturing Records (BMR).
Compliance & Documentation: Maintain meticulous records of production activities, equipment logs, and environmental monitoring in accordance with regulatory requirements.
Aseptic Practices: Ensure strict adherence to aseptic techniques and cleanroom protocols (Class A/B/C/D) to prevent contamination.
Equipment Management: Oversee the operation, cleaning, and sterilization (autoclave/SIP/CIP) of manufacturing equipment.
Team Leadership: Coordinate with machine operators and helpers to meet production targets while maintaining safety standards.
Troubleshooting: Identify and resolve technical issues during the production process to minimize downtime.
Requisitos
Required Qualifications
Education: B.Pharm / M.Pharm / M.Sc in Chemistry or a related field.
Experience: 2–5 years of experience in sterile injectable manufacturing.
Technical Skills: Deep understanding of aseptic processing, sterilization cycles, and cGMP/WHO-GMP guidelines.
Attributes: Strong attention to detail, problem-solving skills, and the ability to work in a fast-paced, high-stakes environment.