Visual Inspection Technician
Description:
The Visual Inspection Technician will support biologics operations in a pharmaceutical setting, ensuring compliance with safety, regulatory, and organizational requirements. The role involves final product inspections, in-process testing, and documentation in line with cGMP guidelines.
Responsibilities:
- Support biologics operations in pharma, adhering to safety, regulatory, and organizational requirements.
- Document all activities in compliance with cGMP.
- Perform final product visual inspection.
- Perform intermediary product packaging and in-process testing.
- Monitor process alarms.
- Receive materials from the warehouse, verify documentation, and transfer final materials to inventory.
- Ensure timely and error-free completion of manufacturing documentation per cGMP.
- Diagnose and resolve issues in the visual inspection process.
- Manage the disposal of biomedical, domestic, and hazardous waste, ensuring regulatory compliance.
- Maintain detailed records of operations, either manually or electronically.
- Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and equipment commissioning and qualification.
- Adhere to policies relating to Quality & Safety.
- Ensure success in external inspections and corporate audits.
- Contribute to the development of batch records and electronic batch records.
- Collaborate with Engineering, Quality, and other departments on Standard Operating Procedures (SOPs).
Requirements:
- Leaving Certificate and 1 year of experience in GMP manufacturing.
- Minimum 1 year of knowledge in GMP and regulatory requirements in the pharma/biologics industry.
- 1+ years of batch processing operations experience in an FDA/HPRA regulated environment is highly desirable.
- Annual visual test certification for color blindness and 20/20 vision.
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