Job Location: Long Island City, NY
The Senior GxP Specialist will be responsible for generating, reviewing and remediating computer system validation protocols in order to ensure that Luitpold is meeting regulatory requirements. 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, for all departments within the company
Essential Duties and Responsibilities
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
Partner 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.
Develop department SOPs and provide SOP review for new systems.
Perform Validation/Part 11 Assessments for new and existing computer systems.
Perform scheduled reviews of existing GxP Systems and define remediation plans for non-conformances.
Maintain GxP System 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 guidances 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.
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 demonstrate QUALITY culture and behaviors and perform all duties in accordance with Company 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.
Qualifications and Requirements
Bachelors degree and a minimum of 5 years experience dealing with GxP computer systems in the pharmaceutical or similarly regulated industry. A technical background a plus.
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 lifecycle (SDLC) principles.
Demonstrates the 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.
Demonstrates good coping skills and analytical problem solving skills.
Ability to resolve conflicts and disputes on regulatory compliance issues.
Ability to perform limited travel both domestically and internationally
How To Apply:
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