The Role:
Our Sligo based client is actively recruiting for a Visual Inspection Technician to join their Pharmaceutical site. This contract role is based on a rotating shift pattern (no weekends) and would be ideal for someone with prior GMP experience and strong attention to detail.
Responsibilities
1. Work as a team member to support biologics operation in pharma operations in line with all safety, regulatory and organizational requirements.
2. Be assigned to the daily production operations.
3. Document all activities in line with cGMP requirements.
4. Perform final product visual inspection.
5. Perform product intermediary packaging, as applicable.
6. Perform in process testing methods.
7. Monitor Process Alarms.
8. Receive materials from the warehouse, verifying all pertinent documentation.
9. Transfer final material to warehouse inventory.
10. Ensure all manufacturing documentation is completed in a timely manner without errors, following cGMP’s.
11. Diagnose and resolve events or exceptions of the visual inspection process.
12. Dispose 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.
13. Keep detailed records, manual or electronic, of the operations carried out during the work shift.
14. Actively participate in Factory Acceptance Testing, Site Acceptance Testing, and commissioning and qualification of equipment.
15. Adhere to all relevant policies relating to Quality & Safety.
16. Ensure successful external inspections, and Division and Corporate audits.
17. Participate in the development of batch records and electronic batch records for the site.
18. Work with Engineering, Quality, and other departments in the development and update of Standard Operating Procedures.
Requirements
Essential:
1. Requires annual visual test certification for colour blindness and 20/20 vision.
2. Leaving Certificate and 1 year’s experience in GMP manufacturing.
3. 1 year plus of GMP Knowledge and regulatory requirements relating to the pharma/biologics industry.
4. 1 year in Batch processing operations in an FDA/HPRA regulated industry is highly desirable.
5. Good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry is desirable.
6. Experience in handling dangerous chemicals is highly desirable.
7. Good IT skills are required.
8. Previous Inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to Visual Inspection.
For a confidential conversation about the role contact Owen Clancy at (phone number removed) or (url removed).
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