What are the responsibilities and job description for the Computer Systems Validation Specialist - Simply Biotech position at TalentZok?
Computer Systems Validation Specialist- Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below. Immediate opening for a Computer Systems Validation Specialist with a biotech company in San Diego, CA who possesses : -Bachelor's degree in scientific discipline required, MS / years of experience in pharmaceutical computer system validation, experience with Veeva and EDMS is a plus-Must have knowledge of GAMP 5 regulations, experience with Annex 11 and 21CFR regulations is highly preferred-Must have experience with leading the full CSV lifecycle from end-to-end, experience with CSV within manufacturing is a plus Email resumes to odrow@ FULL DESCRIPTION : The selected candidate will be responsible for : -Develop and execute computer system validation deliverables including but not limited to URS, FRS, Risk Assessment, Design Specification, IQ / OQ / PQ, RTM and Validation Summary Report.-Support global computer system implementation and validation.-Lead computer system validation activities in WBU site.-Ensure computer systems in WBU site are compliance with CSV SOPs.-Provide CSV support in deviation, CAPA, Change Control, and computer system vendor evaluation.-Perform periodic review for computer system used in WBU site.-Support regulatory filings and inspection as CSV SME.-Support CSV remediation activities from external and internal audit. The selected candidate will also possess : -Bachelor's degree in science with 6 years or MS / PhD with 4 years of GMP / Relevant Industry Experience. (Chemistry, biochemistry, or related discipline preferred).-Must have 4 years of experience in pharmaceutical (FDA regulated industry) computer system validation.-Ability to travel less than 10%.-GMP, GAMP, Annex 11, 21CFR knowledge and experience-Statistical analysis-Excellent analytical interpretation skills-Risk-based application of validation principles-Committed to delivering high quality results, overcoming challenges, focusing on what matters-Implementing change initiatives and leading change.-Ability to lead and implement CSV project with minimum supervision.-Strong problem solving and decision-making skills-Good organizational skills and attention to detail.-Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels.-Ability to handle multiple assignments and changing priorities.-Positive, proactive approach to drive assignments / tasks to completion.-Proficiency with Microsoft Word, Excel, PowerPoint-Ability or capable of lifting up to fifty (50) lbs.-Experience of Veeva Quality Management System and EDMS is a plus.-Must have strong hands-on, end-to-end validation experience and application of project controls / management - including familiarity with all project lifecycle phases from requirements gathering through delivery, issues / risk management, change management, release management and retirement management.-Experience with wide range of CSV experience including Manufacturing, Lab and Enterprise CSV experience. Salary Range : $82k-100k / yr For immediate and confidential consideration, please email your resume to odrow@
Salary : $82,000 - $100,000
