Job Description
We are currently recruiting for an exciting opportunity with a leading pharmaceutical organization based in Mayo.
This is an excellent position for anyone who is looking to join a multinational company that excels in its field.
Key Responsibilities:
* Manufacturing of pharmaceutical products at different stages of the lifecycle, including clinical, non-clinical, and pre-clinical material.
* Batch preparation activities (vial washing, load sterilization, area preparation).
* Working aseptically or as required by the classification of the production area(s).
* Performing compounding, sterile filtration, and sterile filling activities.
* Collaborating with vendors on the development/improvement of new and existing systems regarding single-use technologies.
* Preparing components and equipment for processing into Grade A environments.
* Aiding in running a multi-product suite, changing between different product campaigns without issue.
* Performing environmental monitoring.
* Complying with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
* Reviewing and contributing to technical documents, including protocols, reports, and batch manufacturing documents.
* Participating in cross-functional teams with other functions, including R&D, Engineering, Quality, Supply Chain, Operations, and Validation.
Requirements:
* A 3rd level qualification in a relevant discipline and/or 12-18 months minimum experience in the pharmaceutical or medical device industry.
* Experience working in cleanroom environments is essential.
* Prior knowledge of aseptic practices is desirable.
* Strong knowledge of GMP regulatory guidelines, quality systems, drug product manufacturing, and validation is desirable.
* Understanding of autoclave sterilization, depryogenation, and filter integrity testing is desirable.
* Knowledge of lyophilization and freeze dryer operations is desirable.
* Experience with single-use technologies is desirable.
* Well-developed technical writing, organisational, and communication skills are essential.
* Experience working in project and team-based environments is essential.
* A pro-active approach with proven problem-solving skills is desirable.