OverviewHeadquartered in Cork, Ireland, Business Platforms specialises in Manufacturing Execution Systems (MES), CSV, Serialization, and Supply Chain Operations for our clients. We provide consulting services globally to the Pharmaceutical Industry.We partner with our clients to provide expertise and industry best practice to create and realise business value.ResponsibilitiesStrategy Development and ExecutionBusiness Process Analysis and DesignChange ManagementValidationImplementation and SupportDuration and LocationDuration: Full time positionLocation: OnsiteHybrid Working: Can be accommodated WFO/Client Site and WFHRequirements of a CSV Lead7 - 10 years’ experience in GxP Manufacturing is required within the Pharmaceutical / Life Sciences Industries.7 - 10 years’ experience in DCS Automation systems.Guide, develop and lead the overall CSV approach and validation methodology outlined in the CSV program ensuring it is performed as per relevant site procedures / applicable regulations.Generate and approve all key documentation, providing guidance to ensure team alignment to meet project document schedule.Develop & execute Change Controls and Trackwise records for relevant system updates / changes.Develop (and execute where relevant) User Requirements Specifications, Validation Plans, test protocols and summary reports for GXP system introductions or amendments.Set up of GXP System specifications and Standard Operating Procedures (SOPs) to align with industry standards.Draft new or update existing risk assessments to support GXP system operation as they relate to validation / regulatory requirements.Work closely with relevant engineering disciplines & vendors of equipment to ensure deliverables meet qualification requirements.EducationHold a minimum of an Honours Level 8 degree in a Technical/Science/Engineering/Business Information Systems disciplineBusiness Platforms offers an extremely competitive base salary, commensurate with experience and skill-set.Great company benefits; medical and dental insurance, life assurance and pension.Sports & social events.23 days holidays p.a.Business Platforms offers the opportunity for an accelerated career path with a holistic approach to lifelong learning, bespoke one-on-one training and support which will enable you to acquire new skills and develop.At Business Platforms you will work as part of our Global Team, working with industry experts. You will be contributing to a variety of unique and challenging projects.You can expect a positive culture, a collaborative and supportive environment where we encourage new ideas and innovation, to achieve the highest standard of outcomes for our clients.
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