Responsibilities: Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems. uthor validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies). Review and (remote) execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations. Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols. Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols. ssist, investigate and resolve Deviations, CAPA investigations and other potential issues. Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls. Validates software for Laboratory and Manufacturing instruments. vailable to attend meetings as necessary. Periodic Review activities. bility to manage three to four active projects. Waters/Empower. Various Laboratory Instrument Software. Various Manufacturing Instruments Software. Other Enterprise Applications as Required. Requirements: BS/BA required in a related field. 5+ years minimum required relevant experience. Minimum of +7 years in the FDA regulated industry. 5+ years Document Authoring experience, SOP revisioning experience and re-executing protocols. Working knowledge of GMP, 21 CFR Part 11 and Annex 11. bility to work on multiple concurrent project initiatives. Experience with Laboratory and Manufacturing Instrument Software Validation. Experience in validating Enterprise systems (both on premise and cloud). Examples are SAP, Empower, Labware, Veeva. Worked with different validation models from V-Model to CSA. bility to apply Agile and Waterfall methodology. Excellent written and verbal communication skills. Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues. Strong collaboration with colleagues at all levels. Strong customer service and teamwork oriented. bility to take initiative, to be assertive, to lead by example and to build high-quality relationships. Highly flexible, adapting to changes in priorities, requirements and processes is required. French language proficiency is a plus. Katalyst Healthcares and Life Sciences
...be more than just a line on your resume. This position is located at the Dallas Love Field Airport at 7366 Cedar Springs Road Dallas, TX 75235. It pays to be an Intern with Enterprise! Benefits include, but are not limited to: Full-time 40hr per week schedule...
...Federal Express Corporation (FEC) is part of the rapidly growing warehouse and transportation sector that helps keep America, and our... ...their first day of employment!~ Generous paid time off program - work your way up to 5 weeks of PTO a year!~ Medical, dental and...
...: Overview We are seeking a dedicated and professional Chinese Speaking Front Desk Receptionist to join our team. This role is crucial in providing excellent customer service and ensuring the smooth operation of our front office. The ideal candidate will be the first...
...WE ARE HIRING EXPERIENCED INTERPRETERS PER MINUTE!!! LANGUAGE: SPANISH Requirements: ~85% English proficiency~ Steady wired internet connection... ...industry the interpreter works with (healthcare and medical one, specifically). Go into internal professional...