Vacancy expired!
- This role will also provide support services and governance to all supporting IT areas (GPS corporate and sites) to ensure global alignment to the computer compliance, global validation and change control standards.
- Responsibilities also include providing support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned
- Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.
- Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.
- Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
- Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
- Performs related duties as assigned.
- 21CFR11/ EU GMP Annex 11 and GAMP 5 standards Data Integrity Guidance Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements Project management practices and techniques Software development life cycle Computer hardware and software applications including Quality related computer systems, MS Office and MS Project Principles and practices of computer compliance, validation and qualification Knowledge of automated testing practices and tools a plus External and internal inspections
- Stakeholder management in a cross-functional organization Reviewing user, functional and design specifications.
- Reviewing and executing protocols and test scripts Sampling, testing and measuring techniques.
- Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
- Selecting, training, supervising and evaluating departmental personnel Managing multiple projects, duties and tasks, Communicating clearly and concisely, both orally and in writing.
- Establishing and maintaining effective working relationships with those contacted in the course of work.
Vacancy expired!