Job Description
This is an initial 6-month contract position working on a 16/5 shift pattern, with two daily shifts of 07:00 - 15:00 and 15:00 - 23:00, rotating each week from Monday to Friday. No weekends are involved.
Responsibilities
* Support biologics operation in line with all safety, regulatory, and organizational requirements.
* Perform final product visual inspection.
* Document all activities in line with cGMP requirements.
* 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 cGMPs.
* 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.
Requirements
* Leaving Certificate minimum education requirement.
* 1 year experience in GMP manufacturing.
* Knowledge of GMP and regulatory requirements relating to the pharma/biologics industry.
* Annual visual test certification for colour blindness and 20/20 vision.
* Good knowledge of cGMP and regulatory requirements relating to the biologics/pharmaceutical industry.
* Experience in handling of dangerous chemicals.
* Good I.T. skills.
* Possessing previous Inspection experience in a Pharma/Biologics facility.