This role will be responsible for overseeing production activities, ensuring alignment with strategic objectives. The role focuses on maintaining optimal product quality, volume, and cost-efficiency while adhering to regulatory and safety standards. This position involves direct management of production sectors and collaboration with key departments, as well as fostering effective communication with internal and external stakeholders.
Main Responsibilities:
- Assist in managing daily operations of the production section to ensure processes are executed as designed and in compliance with established policies and procedures.
- Prepare timely and accurate reports to meet departmental requirements and standards.
- Ensure adherence to manufacturing practices and regulations to uphold product quality.
- Coordinate production activities to optimize efficiency and meet production targets.
- Troubleshoot and resolve production issues quickly to minimize downtime.
- Review and approve change requests to safeguard product quality and compliance.
- Implement quality risk management procedures to mitigate potential risks.
- Investigate customer complaints and take appropriate actions before product release.
- Develop and execute corrective and preventive action (CAPA) plans to address production challenges and enhance processes.
- Identify opportunities to optimize resource utilization and improve cost-effectiveness.
- Generate and analyze production reports to monitor performance and identify areas for improvement.
- Support the development and training of production staff to enhance skills and ensure compliance with standards.
- Collaborate with other departments to ensure smooth production processes and alignment with overall goals.
- Coordinate with Engineering to maintain buildings, machinery, and equipment for maximum efficiency, supported by a robust operational efficiency system.
- Ensure compliance with safety, quality, and environmental management policies and procedures to guarantee employee safety, regulatory compliance, and environmental responsibility.
- Ensure emergency situations are clearly defined, and all employees are aware of their roles in response.
- Ensure necessary health, safety, and environmental resources are available to achieve objectives.
- Ensure proper implementation of risk assessments, inspections, and corrective actions within established timelines.
- Minimize environmental impact by adhering to approved waste management systems.
Qualifications:
- Bachelor's degree in Pharmaceutical Sciences or a related field.
- Over 7 years of relevant experience in the pharmaceutical industry, including at least 4 years in roles with increasing managerial responsibilities.
- Preferred experience or knowledge in areas such as ophthalmology, prefilled syringes, blow-fill-seal technology, vaccines, or biosimilars.
