Our client, a pharmaceutical company in Mayo is currently looking to recruit a Pharmaceutical Technology Specialist for their Westport site.
The Pharmaceutical Technology Specialist is responsible for the transfer of new products, raw materials and associated technologies to clients site and co-ordinating the manufacture of semi-finished product for clinical studies.
- Providing technical support during the implementation of new process technologies, automated control systems and risk assess any impact to product quality
- Manage projects with respect to safety, timelines, budget and effective communication to team members and stakeholders
- Authoring of supporting Documents and reports as required.
- Management of QMS System for example change controls
- Support Project Vision manager in status updates and details
- Attend all meetings as required or arrange and appropriate deputy
- Liaise with site project teams.
- Coordinates resources from Engineering, Quality Assurance, and production personnel assigned to specific projects
- Generation and execution of protocols for both new and marketed products including the qualification of new chemical raw materials and components.
- Work with other departments to ensure identified work items are addressed in a timely and satisfactory manner.
- Assist the client in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
- Perform all assigned duties according to departmental SOP’s and cGMP’s, and company policies.
- Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
- Complete and remain current with all required cGMP and safety training.
- Perform other duties as assigned.
The Ideal Candidate
- Degree in Science, process/chemical engineering or equivalent
- Pharmaceutical Manufacturing knowledge
- Aseptic Processing Knowledge
- Process Validation Knowledge (CPV)
- Working knowledge of OpEx, Lean Six Sigma and good statistical application
- Clear understanding of working within a regulated environment - FDA/EMEA, ICH and USP requirements for Drug Product development and manufacturing
- Practical working knowledge of statistical data analysis and quality improvement tools and techniques an advantage.
- Experience using proven risk management tools.
For further information on this Pharmaceutical Technology Specialist role in Mayo please contact Clara Burke on 086 8168273 / email@example.com