- Reference: GY43618
- Job Type: Permanent
- Location: Galway, Galway city, Mayo
- Category: Science, Pharmaceutical & Food
- Responsible for reviewing and maintenance of Validation lifecycle documentation to ensure there is sufficient documented evidence to support product manufacturing in accordance with appropriate regulatory agency validation requirements, customer expectations, internal company standards, and current industry practices.
- Provide technical writing & support to quality systems records including; Deviations, CAPAs, and Change Controls which are associated with validated systems.
- Provide sound scientific and compliance expertise during the development of cGMP validation documentation; i.e. protocols, reports, SOPs, etc.
- Responsible for evaluating and maintenance of validation and process data to support recommendations for changes and/or improvements to the process.
- Co-ordinate workshop sessions and develop knowledge sharing platforms supporting the Validation/Technical Departments and knowledge transfer across the site.
- Perform other duties as assigned.
- Minimum of a Bachelor’s degree (or equivalent) in a Technical Discipline with a minimum of 4 years’ post graduate experience in Technical Services / Manufacturing Support /Validation within a cGMP manufacturing environment in a biologics/ pharmaceutical setting.
- Direct experience within liquid & lyo fill finish technology is a strong plus.
- Must have knowledge of current industry best practice & validation requirements for pharmaceutical manufacturing processes.
- Proficiency in speaking, comprehending, reading and writing English is required.
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