Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically VISUAL INSPECTION TECHNICIAN Dept: Operations Reports to: Manufacturing Team Lead Responsibilities ?
To work as a team member to support biologics operation in pharma operations in line with all safety, regulatory and organizational requirements.
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Visual Inspection Technician will be assigned to the daily production operations.
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Documentation of all activities in line with c GMP requirements.
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Perform final product visual inspection.
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Perform product intermediary packaging, as applicable.
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Perform in process testing methods.
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Monitor Process Alarms.
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Material receipt from warehouse, verifying all pertinent documentation.
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Transfer of final material to warehouse inventory.
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Ensure all manufacturing documentation is completed on a timely manner without errors, following c GMP's.
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Diagnose and resolve events or exceptions of VI process.
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Disposal of domestic, biomedical, and hazardous waste from their respective area as applicable, ensuring compliance with regulations following the procedures and policies of the plant, division, and the corporation.
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Keep detailed records, manual or electronic, of the operations carried out during the work shift.
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Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
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Adhering to all relevant policies relating to Quality & Safety.
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Ensure successful external inspections, and Division and Corporate audits.
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Active participant in the development of batch records and electronic batch records for the site.
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Work with Engineering, Quality and other departments in the development and update of Standard Operating Procedures.
Requirements ?
Leaving Certificate and 1 years' experience in GMP manufacturing ?
1 year plus of Knowledge of GMP and regulatory requirements relating to the pharma/biologics industry.
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1 year in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable.
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Essential: Requires annual visual test certification for colour blindness and 20/20 vision.
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A good knowledge of c GMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable.
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Experience in handling of dangerous chemicals is highly desirable.
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Good I. T.
skills are required.
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Possessing previous Inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to VI.
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