Computer System Validation
1 month ago
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 Summary:
The Computer Systems Validation & Data Integrity Consultant position is responsible for independently performing Computer System Validation (CSV) and Data Integrity (DI) related projects and providing consulting and contract services to clients. This role will provide support and guidance for CSV and DI activities, such as executing CSV/DI strategies, developing CSV/DI procedures, and performing CSV/DI gap assessments. Occasional co-authorship and presentation of industry blogs, white papers, training, and webinars on CSV/DI technical topics of current interest is expected.
Essential Functions:
Provide clients with advice and guidance on computer system validation and data integrity compliance approaches.
Work independently and participate in teams of internal resources in delivery of CSV and Data Integrity projects.
Provide CSV services to clients, e.g., authoring CSV deliverables such as Validation Plans, Requirements, Risk Assessments, IQs, OQs, PQs, Trace Matrices, and Validation Reports.
Provide Data Integrity services to clients, e.g., authoring Policies and SOPs, developing training materials, and designing data governance programs.
Participate in the development and delivery of original CSV content on current topics impacting the area of Computer System Validation and electronic data integrity. Examples include blogs, training materials, webinars.
Assist with interviews of ProPharma candidates.
Extensive travel may be required at times.
Other duties as assigned.
Necessary Skills and Abilities:
Experience in the validation of at least three of these computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial, and pharmacovigilance applications.
Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.
Experience in authoring policies and procedures (SOPs).
Working knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.
Working knowledge of FDA, EU, and MHRA GxP regulations and supporting documents, such as those from ICH and PIC/S.
Working knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
Working knowledge of Data Integrity guidance documents, such as those from the US FDA, EMA, MHRA, PIC/S, and WHO.
Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
Educational Requirements:
B.S./B.A. in Software Engineering, Computer Science, Information Technology, or a related field.
Experience Requirements:
Minimum 5 years of experience in the field of Computer System Validation.
Minimum 5 years of experience in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.
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.***
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