CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com
Job Summary:
Responsible for testing and validation activities for enterprise information systems. Primary responsibilities include maintenance of validated state of CooperVision computer system environments and supporting implementation of new systems.
Essential Functions & Accountabilities:
Writes and reviews computer system validation documentation including computer systems validation (CSV) plans, risk assessments, test scripts, data migration plans/reports, traceability matrix and summary reports
Provides input to development of corporate standards, policies and standard operating procedures (SOPs) for Information Systems
Works closely with other compliance analysts and internal audit on harmonizing control requirements and frameworks
Trains and mentors project team personnel (developers, testers, business systems analysts) at company level in computer system lifecycle methodology
Provides guidance with functional/ end user requirements, compliance and system specifications, and ensures that proper documentation is maintained
Provides guidance in planning, implementing, and documenting user acceptance testing
Provides test execution training and assists teams with the discrepancy management
Analyzes formal test results in order to identify weaknesses/failures in control performance and documentation
Reviews requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements
Ensures compliance with internal and external computer system lifecycle policies and regulations
Performs periodic reviews and remediation activities on validated systems
Oversees small projects and/or tasks and phases of larger projects. Responsible for coordinating activities of teams, schedules and resources for assigned tasks or projects
Maintains current system inventory listing
Interacts with auditors (FDA, SOX) to provide necessary documentation
Travel Requirements:
Up to 5% travel per annum
Qualifications
Knowledge, Skills and Abilities:
Experience in Software Quality Assurance and Computer System Validation and Requirements Analysis.
Familiar with Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies and frameworks.
Knowledge of Regulatory Procedures FDA 21 CFR Part 11, Part 820, SOX and ISO3485 with good understanding of GxP related processes including risk based approach and validation
Adherence to IS policies and procedures to ensure quality of service and compliance with regulatory requirements
Ability to engage, interact, and negotiate effectively with IT, QA, validation and business project team members.
Prior exposure to manufacturing, supply chain and logistics operations would be beneficial.
Knowledge of the business enterprise functions and processes.
Good analytical and problem solving skills
Ability to adapt to a fast and dynamic environment.
Ability to effectively translate between functional and technical teams
Ability to follow procedures and produce/maintain supporting documentation
Excellent written, oral, and interpersonal communication skills
Excellent time management
Highly self-motivated, self-directed, and attentive to detail
Extensive experience working in a team-oriented, collaborative environment
Ability to communicate effectively with management
Adapts readily to changes in workload, staffing and scheduling
Work Environment:
Normal office environment
Sedentary to light physical effort necessary to perform the job
Extensive contact with employees and external business partners and vendors
Occasional travel, off-hour meetings, weekends
Experience:
1 to 3 years’ experience in assigned function’s business process and supporting systems
Commensurate Technical experience to perform the job duties
Must be proficient with Microsoft Office and Adobe Acrobat
Experience with automated systems for following activities/functions is helpful:
Enterprise Resource Planning (Oracle E Business Suite)