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Visual Inspection Technician
Posted on Dec. 19, 2024
- Sligo, Ireland
- No Salary information.
- Temporary
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Job description
Role is a shift role - 16/5 (07:00 - 15:00 / 15:00 - 23:00) No weekends.
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.
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