Senior Manufacturing Process Specialist
RK5097
Contract 12 months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



As a core member of the business unit the Manufacturing Process Specialist is responsible for providing technical support to the business unit in ensuring efficient manufacturing while ensuring compliance with GMP, EHS standards at all times.



Duties:

• Development of new and revised manufacturing and cleaning recipes in line with Master Batch book requirements.
• Development of and subsequent reporting on metrics relating the overall end to end performance of the business unit including the preparation of scorecards, dashboard and data for management review.
• Management of investigations (including customer complaints, EHS incidents, NCPs etc.) to ensure timely investigation, root cause analysis and implementation of corrective and preventive actions.
• Management of the manufacturing related aspects of the Change Control system in line with site procedures.
• To participate in HAZOP studies so that potential problems are identified and designed out of processes.
• Identification of opportunities for improvement within the manufacturing process through trend analysis and continuous review of all operations (e.g. completion of Self Inspections/ Internal Audits/process Optimization).
• Partnering with business unit personnel in the proactive identification of innovative solutions to problems.
• Develop re processing /rework strategies, test methods and protocols.
• Attendance at operations meetings as required in support of the Business Units.

• Third level Degree in a science or pharmaceutical discipline.
• 5 years experience in a manufacturing operations role within an Aseptic/Sterile or API or biological/ pharmaceutical industry.
• Strong communicator, organisational skills, adhering to deadlines
• LEAN experience/qualification would be advantageous