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New Brunswick, New Jersey American Cybersystems, Inc.
ACS group has an immediate need for a Validation - Compliance Specialist with experience in the Pharmaceutical Industry. This is a 6 months contract opportunity (with long-term potential) and is located in New Brunswick, NJ . Our client is a leading Pharmaceutical company. Please review the job description below Top Skills 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 andor 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. Job Description Managing and coordinating activities related to cGMP Enterprise Electronic Systems. Duties include leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GPS applications. Responsible for developing policies and procedures and coordinating all activities relevant between the Quality departments, IT validation and information technology in relation to implementation, maintenance and change control of computerized systems. A key focus of this role will be to provide qualitycompliance oversight to all computer system validation related activities across the GPS enterprise. The manager will guide the staff to ensure a comprehensive System Development Lifecycle Methodology in alignment with GAMP 5 requirements. 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 Other responsibilities 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. Qualifications Knowledge of Bachelorrsquos degree in a related field from an accredited college or university, with a minimum of 5 years of related experience 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 Thanks Rahul Gulati ABOUT ACS GROUP. ndash ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies AIC Analysts ComforceHealth HireGenics Recent Recognitions No. 6 Largest IT staffing Firm in the U.S. (2019 SIA) Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA) No. 8 Largest IT Staffing Firm in the U.S. (2018 SIA) Inaverorsquos Best of StaffingRegistered Client Diamond Award (2018). National Class lV Supplier of the Year Finalist and a Regional Class IV Supplier of the Year by NMSDC Inavero's Best of StaffingRegisteredClient Diamond Award Winner(2017) Website