Sr Analyst CLS/WMS

Job description

· Be responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
· Support internal and external Health Authority regulatory audits, ensuring a high degree of Inspection Readiness for Systems in the CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility.
· Be responsible for the approval of SDLC validation documentation deliverables, such as but not limited to Compliance Plans, User Requirements, User Acceptance Tests, Traceability Matrix, and the Compliance Report, including the approval to release system implementation and/or changes for production use
· Work collaboratively with project teams, providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
· Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices moving the organization towards a positive risk management posture
· Build and maintain trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same

Desired profile

Qualifications :

·  BS/BA or equivalent experience in the pharmaceutical/medical device/biotech industry, with experience in Computerized System Validation activities is required.
·  A degree in Computer Science, Information Systems, Business Administration or other related field is preferred.
·  Knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required.
·  Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is preferred.
·  Experience in Testing Management tools like HPALM is required.
·  Strong organizational and technical writing skills required.
·  Superior written and oral communication and excellent Microsoft Office skills are required.
·  Ability to work independently with only high level guidance and supervision.
·  Experience in System design, deployment and validation/qualification is a plus.
·  Experience working in a regulated environment with high emphasis on Validation/Qualification & Compliance of systems and processes is a plus.
·  Working knowledge of utilizing a risk-based approach to documentation and/or experience with Quality Risk Management is strongly preferred.
·  This position may require up to 10% domestic and/or international travel.