In Process Control (IPC) Quality Specialist
6 months ago
Responsibilities:
Manage the HACCP pre-requisite programs and review periodically their effectiveness in mitigating microbiological contamination r..
Responsibilities:
- Manage the HACCP pre-requisite programs and review periodically their effectiveness in mitigating microbiological contamination risk. Revise as required for continuous improvement.
- Work with Cross functional team for FDA audit preparation.
- Worked with plant team, special cleaning activities eg. sanitation break.
- Establish and manage the pest control programs for the plant, collaborate closely with the Pest Control Service provider.
- Participate in internal HACCP/GMP and Quality audit programs.
- Support in OE/Engineering improvement projects to ensure compliance to food safety and hygiene requirements.
- Support Procurement team to ensure existing and new material suppliers meet our Food Safety and hygiene requirements.
- Support warehouse and third-party warehouse service provider to meet our Food Safety requirements and ensure material storage compliance. Participate in facility audit for cGMP, pest control and hygiene as required.
- Coordinate and facilitate activities to maintain and continuously improve plant hygiene standard.
- Establish and manage the hygiene monitoring program for production, warehouse, utilities and adjoining areas, with established test points, sampling frequency and acceptance criteria.
- Review and revise current plant hygiene zoning policy to mitigate physical and microbial product and chemical contamination risks, personal and material traffic flow, gowning and shoe change policy.
- Provide guidance in directing efforts to improve, maintain, and validate sanitation practices and procedures. Continuously benchmark or seek best practice in plant and equipment cleaning protocols.
- Evaluate and approve cleaning accessories and disinfectants used in sanitation procedures.
- Audit cleaning systems and procedures and recommends correction of unsanitary conditions.
- Define scope of works and establishes standards and measures of cleaning effectiveness for third party janitorial services for the plant.
- Implement plant wide programs and activities as communicated by site management and regional/global quality, through effective and cost-efficient hygiene and sanitation programs to mitigate microbiological risks.
- Initiate alignment discussions with operations manager and project engineers for plant improvements on hygiene engineering concepts. Validates and ensures that new projects comply with basic hygiene engineering standards.
- Monitor equipment, building, and grounds for routine and non-routine maintenance/repair for GMP compliances and hygiene engineering concepts in accord with Global guidelines.
- Facilitate initial training (and refresher training) to plant personnel on cGMP (HACCP), hygiene programs, and sharing of significant microbial and hygiene learning to prevent recurrence.
- Perform other tasks, roles or projects that may be assigned by Assistant manager Plant hygiene & Food safety Provides guidance and maintenance of Food Safety System (HACCP), and to maintain and continuously improve plant hygiene standard through ensuring compliance to food safety and hygiene requirement.
- Provide guidance in directing efforts to improve, maintain, and validate sanitation practices and procedures.
Requirements:
- Minimum Diploma in a scientific or technical discipline (Chemistry, Food Science, Microbiology or related) preferred or with equivalent skills and experience.
- Working experience in a Nutritional GMP manufacturing environment preferred. Experience in manufacturing of infant/ follow-up formula/ pharmaceutical will be of advantage.
- Understands quality systems, HACCP which includes environmental monitoring program, pest management program, sanitation program and other pre-requisite programs.
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