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 Product Quality Inspector 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.
? Visual Inspection Technician will be assigned to the daily production operations.
? Documentation of all activities in line with c GMP requirements.
? Perform final product visual inspection.
? Perform product intermediary packaging, as applicable.
? Perform in process testing methods.
? Monitor Process Alarms.
? Material receipt from warehouse, verifying all pertinent documentation.
? Transfer of final material to warehouse inventory.
? Ensure all manufacturing documentation is completed on a timely manner without errors, following c GMP's.
? Diagnose and resolve events or exceptions of VI process.
? 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.
? Keep detailed records, manual or electronic, of the operations carried out during the work shift.
? Active Participation in Factory Acceptance testing, Site Acceptance Testing and commissioning and qualification of equipment.
? Adhering to all relevant policies relating to Quality & Safety.
? Ensure successful external inspections, and Division and Corporate audits.
? Active participant in the development of batch records and electronic batch records for the site.
? 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.
? 1 year in Batch processing operations in an FDA/ HPRA regulated industry is highly desirable.
? Essential: Requires annual visual test certification for colour blindness and 20/20 vision.
? A good knowledge of c GMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable.
? Experience in handling of dangerous chemicals is highly desirable.
? Good I.
T.
skills are required.
? Possessing previous Inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to VI.
Work location - Onsite Job type - Full-time Shifts - 16/5 shift@Extra (23:00 - 07:00).
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