(Certified Public Accountant) Validation Analyst
PharmaLex
Makati City, Metro Manila, PH
2d ago

VALIDATION ANALYST

Main Description of Role :

  • Design and develop Computer System / Process validation deliverables - validation plan, user requirements, functional specifications, platform protocol and application protocols in the areas of materials management, warehouse management, production planning, quality management, sales and distribution, plant maintenance and system wide within the accounting and / or ERP systems in compliance with Good Automated Manufacturing Practices (GAMP), FDA regulations (21 CFR Part 11, 211, and 820), and other IT quality system regulations (as applicable).
  • Review and write Systems Development Life Cycle and validation documentation in
  • compliance with Standard Operation Procedure’s and Business Process Procedures based on client’s need.

  • Prepare walkthrough narratives and process flow diagrams to identify key Good
  • Manufacturing Practice (GMP) controls in assigned business blueprints. Identify processing risks, mitigating controls procedures, control gaps and ineffective internal control procedures.

  • Prepare test cases and scripts for audit trail, electronic signature, security access and
  • control, system connectivity, and other platform specifications. Assist in developing inspection

    plan for master and transactional data migrated to the system prior to go-live. Collaborate with

    system owners to set-up and validate user security plan (e.g., user groups, roles and profiles).

  • Execute validation protocols, prepared deviation reports on system errors, and
  • recommended resolutions. Interact with business unit management and staff members of IT as

    deemed necessary. Coordinate with ERP system implementation team and users to implement,

    document, and establish security controls.

  • Analyze and prepare test cases and script for changes made in SAP, accounting system,
  • tailored to the client’s requirements and IT Change Control Procedures.

  • Review and assess existing client’s IT Standard Operating Procedures for updates.
  • Develop IT Standard Operating Procedures as per client’s need.
  • EDUCATION, EXPERIENCE, AND SKILLS

  • Bachelor's Degree or equivalent combination of education and work experience
  • CPA passer

  • Preferably with 3 years audit experience
  • Proficient English verbal and written communication skills
  • Exceptional attention to detail
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