| Need CSV Engineer (MES systems and batch record validation focus) on-sit Seattle, WA at Seattle, Washington, USA |
| Email: [email protected] |
| Hi! Greetings of the day, My name is Anushka Verma, and I am a Staffing Specialist at Cloud Space LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Position: CSV Engineer ( MES systems and batch record validation focus) Location: On-site Seattle, WA. Requirements: Authors, executes and/or reviews validation documents such as validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations for Computer and IT systems. Expertise in MES/Delta-V/LIMS Manufacturing CSV systems and batch record validation. Schedules and executes validations per ASTM, GAMP V, standard operating procedures and regulatory guidelines. Lead assigned validation related investigations and conduct data integrity (DI) assessments with DI remediation planning. Champion and lead continuous improvement efforts on every aspect of validation Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions. Foster cross-departmental relationships (QC, Materials Management, IT, Manufacturing, QA and site leadership) by representing Validation at team meetings. Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents. Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.. The candidate must be eligible to work in the US. Thanks and Regards Anushka Verma US IT Recruiter Cloud Space LLC Email: [email protected] Website: www.cloudspacetek.com Address : 1909 J N, Pease Place, Suite 201, Charlotte, NC 28262 Linkedin- Anushka Verma | LinkedIn -- Keywords: quality analyst access management information technology North Carolina Washington Need CSV Engineer (MES systems and batch record validation focus) on-sit Seattle, WA [email protected] |
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| Fri Aug 30 00:20:00 UTC 2024 |