Manufacturing Process Specialist required for mulitnational API manufactring facility based in Cork.
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.
o Development of new and revised manufacturing and cleaning recipes in line with Master Batch book requirements.
o Preparation of Process & Cleaning Validation protocols and reports as required by the business unit and coordination with other business unit partners to ensure all other validation requirements are met in line with the Site Validation Master Plan (e.g. analytical validation)
o Completion of any Equipment & Computer system Qualification as required by the business unit.
o Production of Annual Product Review reports for all products relating to the business unit.
o 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.
o Management of deviations (including customer complaints, EHS incidents, NCPs etc) to ensure timely investigation, root cause analysis and mplementation of corrective and preventive actions.
o Management of the manufacturing related aspects of the Change Control system in line with site procedures.
o Relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
o 4 + years relevent experience
o Understanding of the requirements of cGMP and familiarity with other relevant regulatory requirements
For full details on this role please contact Kathy or apply directly through this advert,