Product Quality Assurance Role
This position involves working within a team environment to support biologics operations in line with all safety, regulatory and organizational requirements.
The role will involve working closely with colleagues across various departments to ensure the delivery of high-quality products.
Key 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 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.
* 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 IT skills are required.
* Possessing previous Inspection experience in a Pharma/Biologics facility is a distinct advantage for operators assigned to VI.
Benefits:
As a Visual Inspector in our organization, you will have the opportunity to work in a dynamic and fast-paced environment. You will be part of a dedicated team that is committed to delivering high-quality products to our customers.
Our company values its employees and offers a range of benefits to support their well-being and career development.
Others:
We are committed to providing a safe and healthy work environment for all our employees. We follow all relevant policies and procedures to ensure that our workplace is free from hazards and risks.