- Develop and/or review/approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, User Acceptance Tests (UAT), Design Qualification (DQ), IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
- Provide QA oversight of all GxP computerized system validation activities: conduct/lead GxP assessments, risk assessments, part 11 assessments.
- Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
- Coordinate validation/qualification activities, propose and implement validation/qualification strategies and serve as the subject matter expert.
- Present project status reports to management as well as project teams.
- Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
- Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
- Lead/participate in supplier site Validation Assessments/Audits and work with suppliers to troubleshoot and improve systems and processes. Generate System Assessment/Audit Reports and follow-up with suppliers on implementation and closure of observations/recommendations identified in the report.
- Generate or review/update computer system related policies, procedures, templates, forms, etc., as needed to improve/evolve the validation program and implement them.
- Work with Management on system validation planning (both short term and long term) supporting diagnosis of validation problems (both internal and external), implementing corrective and preventive actions to resolve those problems, and support continuous improvement of validation programs.
- Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures.
- Involve in review and revision of Standard Operating Procedures (SOP).
- Performs other quality and computerized system related duties as necessary.
Job Types: Contract, Full-time
Pay: $40.00 - $55.00 per hour
Schedule:
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Contract Length:
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Work Remotely:
- Temporarily due to COVID-19
Work Location: Multiple locations
