*** MUST BE ABLE TO WORK ON AN EMPLOYEE BASIS *** NO C2C *** REMOTE/onsite blend***
Our Client is expanding and currently seeks a
VALIDATION COMPLIANCE SPECIALIST
For a 6+month assignment with possible extensions!!
LOCATION: New Brunswick, New Jersey
***Position is currently remote, but must report to this office once the COVID
restrictions are lifted***
Leverage your GxP - GAMP 5 & TECHNICAL skills
to help take your career with our Client to
the "Next Level" for 2021 and beyond!
Our Client is seeking a Validation Compliance Specialist to become part their Compliance department.
A key focus of this role will be to provide quality/compliance 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.
• Managing and coordinating activities related to GxP Enterprise Electronic Systems. Duties include leading, developing, and maintaining compliance activities across IT Enterprise Services supported regulated GxP 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.
• Provides 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), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) 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.
Experience & Education:
• Minimum of 5 years of related experience
• Bachelor's degree in a related field from an accredited college or university.
- There is no per diem with this position
- There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
- MUST be able to work without sponsorship or VISA transfer for this position.
By partnering with Kelly® Technology, you'll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today's most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, keep learning, and move your career forward.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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