*Please send me profile on my id vsaras...@tekshapers.com <vsaras...@tekshapers.com>*
*Position:- Validation QA Analyst* *Location: Tarrytown, NY* *Duration: 6 Months* *MOI: Phone + In Person* *Job Requirement:* *The following are the tentative requirements and responsibilities for the position (including but not limited to):* · The review/revision of SOPs; in some cases may do the heavy lifting and in others it may be limited to facilitation and assistance to the SME · Representing the IT department in the "Notice of Event" (NOE) meeting (daily GMP NOE meeting) · Assisting IT personnel in writing/responding to NOEs and Evaluation of Event (EOEs - root cause analysis) · Assist in the tracking of and facilitate the remediation activities associated with IT-related CAPAs · Assist IT-QA in proactive self-assessments within the IT department and make recommendations for improvement · Assist IT-QA in developing/implementing an "internal assessment" program, to include the use of external 3rd party "auditors" to conduct internal assessments · Assist IT department personnel in navigating through and participating in the GxP Change Control Process · Assist IT department personnel in navigating through and participating in the GxP Document Management Process, including coordinating and/or completing representing IT as an interface to the GxP Document Management process · Facilitate the document management associated with GxP Electronic Document Management System (EDMS - Qumas eDocCompliance) · Assist IT-QA and QA-Validation personnel with the refinement/implementation of the CSV and IT Infrastructure Qualification Programs · Assist It Personnel in interactions with the GxP Quality Assurance personnel and GxP Quality Management System (mainly Qumas QProcessCompliance) *The following are the desired qualifications/experience:* · 5+ years in a QA role, strong preference for QA role within the IT department · 5+ years of experience working within an IT department · Strong preference for GAMP 5, 21 CFR Part 11, GxP, and Annex 11 working knowledge · ITIL and ITSM knowledge is highly desirable · Must be able to help non-IT personnel understand the IT Department limitations and constraints · Ability to author/create technical and SOP documents, assist/mentor others, and/or review/revise existing documents · Excellent attention to detail, computer skills, and ability to successfully communicate both verbally and via written words Vijay Saraswat Talent Acquisition Executive Tekshapers Inc. |1441 E Maple Rd,Suit#301,Troy,Michigan, USA Tel Off: 248.565.4747 | Ext. 108| F: 248.254.7211 | Email Id: vsaras...@tekshapers.com <hgul...@tekshapers.com> | W: www.tekshapers.com GTalk: vsaras...@tekshapers.com <ras...@tekshapers.com> * Please consider the environment before printing this email. Go Green!* *!!!* *Disclaimer:* If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message. If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line at rem...@tekshapers.com 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. -- -- To unsubscribe from this group, send email to cbe-software-engineer-unsubscr...@googlegroups.com For more options, visit this group at http://groups.google.com/group/CBE-Software-Engineer?hl=en --- You received this message because you are subscribed to the Google Groups "CBE Software Engineer" group. To unsubscribe from this group and stop receiving emails from it, send an email to cbe-software-engineer+unsubscr...@googlegroups.com. For more options, visit https://groups.google.com/d/optout.
