GerTEK 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.
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 cGMP 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 cGMP'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 cGMP 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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