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For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Job description
We are currently searching for an independent CSV Consultant ideally with DI experience to assume a new project we have on a freelance basis. This project will last approximately for 9 months; it will ideally commence as soon as possible and will offer 1.0 FTE (40 hour week). This role can be performed on a Hybrid basis ideally with more onsite presence at the start of the assignment.
Essential Functions Include:
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Participate and lead CSV activities linked to DI projects
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Provide guidance to computer system validation and data integrity compliance approaches.
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Independently and participate with larger teams of resources in delivery of CSV and Data Integrity projects.
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Provide CSV services which could include e.g., authoring CSV deliverables such as Validation Plans, Requirements, Risk Assessments, IQs, OQs, PQs, Trace Matrices, and Validation Reports.
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Act as the SME within CSV as and when needed
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Support key initiatives and offer concise advise on a range of topics linked within the CSV automation space
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Support other on-going activities as and when needed
Qualifications
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B.S./B.A. in Engineering, Science, Information Technology or related field.
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Must demonstrate skills in CSV with the life-science industries
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Data Integrity experience would be highly preferred
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Fluent in English
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Can work on a Hybrid approach in Ireland as designated within the Job description
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Can perform the project to the designated requirements in the Job description
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Flexible with strong stakeholder management skills
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
