Change Management Coordinator Duration: 1 year
Location: Groton CT * Change Management Coordinator; The Change Management Coordinator manages all aspects of the change control process. o Manages CR mailbox/queue o Reviews CR's for completeness for IAT and CCB as well as Review and Approval sign off o Requests clarification and additional information if needed o Assign CR numbers o Track CR status * Assess the impact of each Change Requests (CR) on the validation elements: o 21 CFR Part 11 Assessment o Validation planning o Computer validation report o Periodic Review o Vendor evaluation o Change Control o Business continuity o System Decommissioning * Assess if change requests fall under Artifact Request For (ARF), Controlled Data Value (CDV) or CR * Assess impact to existing data for each CR (i.e. do we need in place migration) * Help enforce GDMS guiding principles * Assess implementation paths for each CR (i.e. help desk vs pacc?) * Assess deployment and migration dependencies * Coordinate/assign CR's to DMs or SME's * Review each CR to assess if it has been properly analyzed * Work with CR Coordinator to track CR progress * Set/facilitate follow up discussions * Assist in Change Management (CM) process improvements * Manage issues and risk in Issue Project Management (iPM) associated with CM and/or requirements gathering * Serve as CR SME for CCB Chair and IT Lead o Track CM improvements through metrics Thanks & Regards, Harisha Mahendrakar, Attic Technologies Inc. 333 Cedar Ave, Middlesex, NJ 08846 732-623-9966 ext 305 or 209 | Fax: 732 875 0448 | [email protected] |www.attictechnologies.com | ************************************************************************ Note: We respect your Online Privacy. This is not an unsolicited mail. Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include Contact information and a method to be removed from our mailing list. If you are not interested in receiving our e-mails then please reply with a "remove" in the subject line and mention all the e-mail addresses to be removed with any e-mail addresses which might be diverting the e-mails to you. I am sorry for the inconvenience caused to you. ************************************************************************
