Hope you're doing well! Me: Daniel Hoffman I am a Staffing Manager/Recruiter for Panzer Solutions LLC , and I focus on long-term relationships with my candidates and clients. My hope is that you will be able to call me for years and that I will be here to help you out whether I place you or not.
Position:Validation Analyst. Location:Cambridge, MA Duration:6+ Month (Contract) *Job Requirements*As a member of the IT Quality & Regulatory Compliance team, the IT Analyst Regulatory Compliance helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT systems. *PRINCIPAL DUTIES & RESPONSIBILITIES:* • Approve system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. • Represent IT Quality & Regulatory Compliance on cross-functional teams in support of SDLC activities. • Consult on the authoring and conformance of validation-related deliverables and activities in regard to corporate SOPs and current regulations. • Provide guidance, training, and support to IT personnel in their validation efforts, to ensure compliance. • Provide quality assurance oversight for system related issues (deviations, incidents, etc.) *QUALIFICATIONS: *• Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines • Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL • Excellent communication skills, both verbal and written • Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment • Experience with risk analysis and risk management practices and tools • Five or more years of experience in computerized system validation within a regulated environment Regards, Daniel Hoffman | Staffing Manager | [email protected] | Panzer Solutions LLC. | 45 Stuart Ave • K Unit • Norwalk, CT • 06850 203-652-1444*263|Fax: 203-971-8354 | Notice of Confidentiality: The information contained herein is intended only for the confidential use of the recipient. If the reader of this message is neither the intended recipient, nor the person responsible for delivering it to the intended recipient, you are hereby notified that you have received this communication in error, and that any review, dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this in error, please notify the sender immediately by telephone, and destroy this e-mail message OR reply with the subject “REMOVE” such that your email would be taken out of our distribution list. -- You received this message because you are subscribed to the Google Groups "Open Source J2EE frameworks" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/open-source-j2ee-frameworks. For more options, visit https://groups.google.com/d/optout.
