Sr. Architect SRARCH
Job Location:
West Point, UT - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Lab System Validation
West Point PA
Max SBR: $60-65
JD:
o Experience/ exposure to Computerized System Validation (CSV) US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5.
o Experience of CSV Validation in any one of the Lab systems is must.
o Should worked in pharmaceutical domain and its related knowledge is must
o Good communication and technical writing skills are a must
o Developing validation documentation for pharmaceutical equipment facilities and computerized systems used in GLP GMP and GCP environments.
o 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.
o CSV GAMP 5 CPFR Part 11 Validation Worked in V model SOP & SDLC Lifecycle. Adaptation of CSA and Module Validation is preferred.
o To provide a planned approach for the implementation of the CSV deliverables migration due diligence GXP and Non GXP areas
o Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirement.
o Prepare and execute URS MVP VP RTM TP IQ OQ PQ VSR Traceability Matrix etc.
o Exposure to Regulatory Audits and Remediation activities
o Ensure the CSV artefacts are in line and meets regulatory requirements
o Preferred Experience in Agile Development
o Knowledge on working in Jira / Service Now
o Adaptation to AI is preferred.
Testing (in addition to above)
o Experience in testing and knowledge in any one of the QC/R&D Lab systems is must.
o Prepare and execute TP IQ OQ PQ TSR Traceability Matrix etc is must.
o Knowledge on working in Jira HP ALM or any automation testing tools.
