QA GxP Systems Team Lead

Company: American Regent, Inc.
Location: Shirley
Posted on: February 25, 2021

Job Description:

The QA GxP Systems Team Lead will be responsible for generating, reviewing and remediating computer system validation protocols for the Chemistry and Microbiology laboratories in order to ensure that all regulatory requirements are met. They will undertake a wide range of duties relating to the leadership of projects. These responsibilities will include but are not limited to: the planning, execution, monitoring, controlling and delivery of projects. The QA GxP Systems Team Lead will work closely with members of the GxP team, IT, QA Compliance team and Senior Management.
-- Essential Duties and Responsibilities--

• Extensive knowledge of FDA guidelines and regulations.
• Extensive knowledge of GAMP5.
• Ability to create comprehensive status reports.
• Ability to independently manage small projects, from the initiation phase through to deployment.
• Escalate any unresolved issues to Upper Management, and follow through to resolution within required timelines.
• Collaborate with IT to gather infrastructure and architectural requirements pertaining to relevant projects.
• Manage all project and compliance related issues associated with their project.
• May support, coordinate and interface with regulatory agencies as required in support of regulatory agency inspections.
• Support and maintain Quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
• Consistently perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Create and implement business continuity plans, procedures and enhancements
• Review IT Infrastructure vendor operations and outsourcing arrangements and collaborate with major service providers of IT Infrastructure
• Perform infrastructure qualification activities, testing sequences and change controls. Oversight of execution with IT team members.
• Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, Unit test scripts, UAT scripts, validation plans, validation summary report, traceability matrix, IQ/OQ/PQ
• Develop department SOPs and provide SOP review for new systems.
• Perform Validation/Part 11 Assessments for new and existing computer systems.
• Maintain GxP Systems Inventory Log and update as necessary.
• Participate in cross-functional project teams.
• Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices as well as latest regulatory guidance's and regulatory updates.
• Conduct validation related training to individuals performing various roles within validation projects.
• Participate in the development and improvement of computerized systems to ensure quality and adherence to cGMPs. Qualifications and Requirements
  • Bachelor's degree and a minimum of 7+ years' experience dealing with GxP computer systems in the pharmaceutical or similar regulated industry. A technical background a plus.
  • 2+ years' experience managing/supervisory of computer system specialist teams.
  • Strong understanding of the current pharmaceutical industry and computerized system regulations, including CFR Part11.
  • Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
  • Experience in providing oversight in implementing and maintaining GxP computer systems in a validated state.
  • Strong working knowledge in validation methodology and software development life cycle (SDLC)principles.
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  • Excellent verbal, written and interpersonal communication skills.
  • Effective time management and interpersonal skills.
  • Strong organizational skills, planning skills and must work effectively within teams.
  • Strong analytical problem solving skills.
  • Ability to resolve conflicts and disputes on regulatory compliance issues.
  • Ability to perform limited travel both domestically and internationally. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Posted 7 Days Ago Full time R-100373 About Us Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.

Keywords: American Regent, Inc., Stamford , QA GxP Systems Team Lead, Other , Shirley, Connecticut