The Senior GxP Specialist will be responsible for generating, reviewing and remediating computer system validation protocols in order to ensure that the company 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 internal departments. The Senior GxP Specialist will work closely with members of the GxP team, QA Compliance team, and senior management.
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.
- May support, coordinate, and interface with regulatory agencies as required in support of regulatory agency inspections.
- 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.
- 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.
- Support and maintain Quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
Education Requirements and Qualifications
- Bachelor's degree and a minimum of 5 years' experience dealing with GxP computer systems in the pharmaceutical or similar regulated industry.
- Strong understanding of the current pharmaceutical industry and computerized system regulations, including CFR Part 11.
- Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice 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.
- 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.