| GMP IT Systems Analyst || Greater Seattle, WA || Seattle, Washington || skype at Washington, DC, USA |
| Email: [email protected] |
| From: Neha, Tek Inspiration LLC [email protected] Reply to: [email protected] Hello, Hope you are doing well, Please check the below job description and let me know if you have any suitable candidate for the same: Job Description - Job tittle : GMP IT Systems Analyst GMP IT Systems Analyst to support a Biopharma manufacturing site. Domain : Biopharma manufacturing 100% ON-SITE (Greater Seattle, WA). The IT Systems Analyst, GMP Systems will be supporting GMP critical systems within the Manufacturing and/or Laboratory environments of CLIENT manufacturing sites. The incumbent will have strong technical skills as well as experience in working within the constraints of GMP regulatory requirements. WHAT YOU WILL DO Take over the responsibility as a System Owner for Manufacturing IT Applications and/or QC Analytics systems in a 24x7 Good Manufacturing Practice (GMP) environment. Work with the Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance. Perform system administration, support/troubleshooting, and lifecycle management activities for supported systems. Work to identify opportunities to create additional value and improve business processes, compliance, and maximize the benefits of standardization of technologies and leverage across sites. Assist with system validation and lifecycle management processes. Determine business criticality and product quality requirements, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support. Lead or coordinate technical discussions and vendor negotiations. Support regulatory audits as needed. ABOUT YOU Bachelors Degree in Information Technologies, Engineering, Sciences or equivalent experiences. 3+ years of experience implementing and managing GxP computer systems in the manufacturing or laboratory domains. IDEAL CANDIDATE Business domain knowledge for the following area(s): Biopharmaceutical or similar Manufacturing domain. Experience as a System Owner for validated GxP Systems. Familiar with Data Integrity methodologies. Experience writing Standard Operating Procedures (SOPs). Basic understanding of Computer Systems Validation Basic knowledge of Manufacturing Execution Systems, Distributed Control Systems (DeltaV), LIMS, Data Historian, ERP etc. Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11,cGMP Annex 11, Data Integrity principles. Regards, Neha Suryavanshi IT Recruiter TEK Inspirations LLC : 13573 Tabasco Cat Trail, Frisco, TX 75035 Email: [email protected] LinkedIn : https://www.linkedin.com/in/km-neha-34b558229/ Disclaimer: If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line to [email protected]. And mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. Keywords: information technology Texas Washington GMP IT Systems Analyst || Greater Seattle, WA || Seattle, Washington || skype [email protected] |
| [email protected] View all |
| Thu May 16 19:10:00 UTC 2024 |