DirecciónPrimary Function/Primary Goals/Objectives:
- Lead Food Safety risk assessment and quality records (QRs) for escalation on lines as per Global GMP lifecycle policy.
- Provides support and inputs to update Food Safety Policy and site HACCP.
- Provide support to the Manufacturing organization to facilitate the efficient operations within the production area.
- To optimize existing processes and to ensure that production goals are met. Ensures systems and processes to maintain GMP at workplace.
- Collaborate with Operations sub-functions in tracking critical production and cleaning parameters to track and collate responses for consumers/medical/affiliates escalations.
- Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that can produce non-conforming products.
Major Responsibilities:
- Responsible to Manage and focus directly on GMP Food Safety engineering/food security and validation, in preparation for the commercial production of regulated products.
- Lead projects of facilities and equipment and optimization of existing manufacturing processes to deliver products with the production requirements consistent with Gold Standard Policies.
- Responsible to perform quality events investigation and coming up with CAPA action. Ensuring the effectiveness of CAPA action.
- Responsible to Motivate, develop and train employees for the facility and from third party as part of Food Safety program.
- Lead incident reviews to investigate and correct microbiological non-conformities and provide recommendation regarding process design, product disposition and continuous improvement.
- Optimize the documentation for quality systems, cleaning and validation, SOPs, HACCP plans, and Food Safety policy and protocols.
- Ensures plant Food Safety documentation is maintained in an audit-ready state, meeting all statutory, regulatory requirements & customer expectations.
- Ensures the effective use of materials, equipment, and personnel in producing quality products at an effective operating cost.
- Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.
- Prepares reports, publishes, and makes presentations to communicate findings.
- Partner with Engineering on the installation, modification, upgrade and maintenance of manufacturing equipment.
- Implement, document, and maintain controlled, repeatable production processes.
- Development of qualification and validation protocols.
- Participate in and/or lead qualification and validation activities.
- Interface with other departments and suppliers to address root causes.
- Understands the business needs of the company and has knowledge of the customer needs of our business.
- Cultivates internal and external network of resources to complete tasks.
- Any other duties as assigned by supervisor.
Skills/ Experience Requirements:
- 1 to 4 years of related experience.
- Knowledge in SAP system/POMS/MES.
- Knowledge about food microbiology, pathogens and Food Safety.
- Able to make fast decision and react efficiently to situation.
- Understands engineering principles, theories concepts, practices and techniques
Education:
- Bachelor’s degree in Process Engineering/ Mechanical/ Electrical/ Food Science
- Biotechnology/Microbiology or in related discipline or with a minimum 1-4 years of related experience.
