*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. -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at http://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
