(certified public Accountant) validation analystPharmaLex
Workplace: MetroManila, Manila, Makati
Salary: Agreement
Work form: Full time
Posting Date: 19/11/2023
Deadline: 28/12/2022
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
Required CPA passer
Preferably with 3 years audit experience
Proficient English verbal and written communication skills
Exceptional attention to detail
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PharmaLex
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
Required CPA passer
Preferably with 3 years audit experience
Proficient English verbal and written communication skills
Exceptional attention to detail
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PharmaLex
Other Info
Makati City, Metro Manila
Permanent
Full-time
Permanent
Full-time
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PharmaLex
About the company
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