Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 2+ years of hands-on CSV experience in pharma, biotech, or medical device environments. Strong working knowledge of GxP, FDA regulations, and SDLC methodologies. Experience validating cloud-based or SaaS GxP systems is a plus. Excellent documentation, communication, and collaboration skills. Katalyst Healthcares and Life Sciences
...Company parties ~ Competitive salary ~ Free uniforms ~ Paid time off ~ Signing bonus We are seeking an experienced gutter installer to add to our team. We manufacture our gutters on site and install on residential and commercial buildings. We typically only...
...experience)Swipe Say Easy We are seeking a motivated and dynamic Entry Level Communications Agent to join our team. This position is... ...looking to kickstart their careers in communications, public relations, or corporate communications. As an Entry Level Communications...
...Job Description Job Description Research PA and DE state Medicaid laws and regulations; Interpret and apply laws and regulations to case decisions; Review evidentiary exhibits, including affidavits, sworn testimony, and medical documentation; Compose...
...will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career...
...strategies, assist with donor relations, and support the organization'... ...marketing, media relations, and public relations, preferred.... ...cooperatively with others at all levels of the organization including... ...level ~ Seniority level Entry level Employment type...