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. 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.
Project required
ProPharma is currently supporting a global life-sciences brand as they are looking for a Validation SME for a key Tracelink Computer System Validation project. This specialised project requires substantial skills working with the Tracelink system ideally validating/troubleshooting aspects while providing suggestions/implementing improvements where necessary. This project pays per hour; it requires an immediate start and will run for 3-6 months at least depending on the initial project outcome. Furthermore, it can be performed fully remotely from anywhere in the UK/EU (only) and it could require up to full time hours (hours dependent on project progression) at the beginning.
Responsibilities included:
OPUS Assessment including functionality, best-practice use cases, cost-benefit analysis (ROI), and phased implementation strategy development.
Created a detailed assessment report recommending the optimal implementation scope, timeline, and a clear impact analysis
Assess Tracelink and its alternatives which includes compliance aspects, migration feasibility etc.
Compliance review and process definition which includes a GAP analysis and updating any aspects to Regulatory compliance
SN Scanning & Aggregation
SOP development which includes drafting compliant SOP’s with suppliers and verification procedures
Act as the SME to the client and provide overall direction to the client
Experience required
Must have achieved at least a BSc or higher within a Life-sciences, Engineering or IT discipline with substantial exposure to working in CSV in Pharma/Biotech
Demonstrated expertise working on troubleshooting activities with Tracelink technology ideally within a Validation project
Substantial exposure to working in CSV within the life-science sector is a must
Excellent analytical and project management skills
Fluency in English
Can perform the project as designated within the job description
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