Lab System Validation

Lab System Validation#26-20332 $42.85-$46.42 per hour West Point, PA Onsite Job Description Our client, a IT Services and Consulting company, is looking for a Lab System Validation for their West Point, PA location.

Requirements:

Experience/ exposure to Computerized System Validation (CSV), US

FDA 21 CFR

Part 11, EU Annex 11 and GAMP 5. Experience of CSV Validation in any one of the Lab systems is must. Should worked in pharmaceutical domain and its related knowledge is must Good communication and technical writing skills are a must Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments. Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.

CSV, GAMP 5 CPFR

Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred. To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement. Prepare and execute URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix etc. Exposure to Regulatory Audits and Remediation activities Ensure the CSV artefacts are in line and meets regulatory requirements Preferred Experience in Agile Development Knowledge on working in Jira / Service Now Adaptation to AI is preferred. Testing (in addition to above) Experience in testing and knowledge in any one of the QC/R D Lab systems is must. Prepare and execute TP, IQ, OQ, PQ, TSR, Traceability Matrix etc is must. Knowledge on working in Jira, HP ALM or any automation testing tools.

Years of Experience:

11.00 Years of Experience

Skills:

Category Name Required Importance Life- Sciences GAMP Yes 1 Vantage CSV Yes 1