- Responsible for quality computer system administration, providing technical/end user support for quality computer system, and maintaining close communication with management to keep stakeholders apprised of quality computer system incidents/ resolutions, project validation status, and other relevant issues. The role requires leading and/or assisting in quality computer system validation efforts and ensuring all work is carried out in compliance with cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex 11, ICH guidelines, and other applicable industry regulations.
- Manage new and existing quality software systems from inception to deployment, including the design, configuration, validation, implementation, and maintenance activities for the system(s).
- Develop and maintain a strong partnership with internal departments and quality users to achieve business and project goals.
- Generate and maintain validation documentation deliverables such as URS, FRS, Configuration Specification (CS), and Requirements Traceability Matrix (RTM), and system procedures (SOPs) in accordance with cGMP, 21 CFR Part 11, EU Annex 11, and related regulatory requirements to ensure the system is maintained in a validated state.
- Draft, execute, and review qualification protocols and analyze results to verify that acceptance criteria for the protocols are met.
- Ensure project deadlines and performance standards are met while communicating status accordingly.
- Review scheduled system releases/upgrades and determine impact on quality processes and system configurations.
- Recommend possible implementation scenarios to the business.
- Partner with the software vendor to support the system and manage the release schedule with the vendor and the business.
- Accountable for technical support and system troubleshooting.
- Provide daily support for end users on system navigation and business process questions.
- Accountable for management of user access (on-boarding/off-boarding), technical support, system troubleshooting.
- Support inspection activities as needed for self-inspection, client inspection, or regulatory inspection (e.g. backroom support, on deck support, etc.)
- Bachelor’s degree (or Associate Degree and additional related work experience) in pharmaceutical science, biology, chemistry, or related science/IT.
- Requires working knowledge of FDA and/or EMEA regulatory requirements/guidelines as they relate to all aspects of quality systems and compliance (i.e., 21CFR Part 11, Data Integrity, etc.).
- Skills in:
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.