Hope you're doing well! Me: Abid Hassan I'm 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.
Title: Sr Regulatory Compliance SME, Pharma, FMEA, GAMP 5, QA Location: Chicago, Illinois Contract Duration: 6 months Travel will be involved but expenses will be covered by client Minimum Requirements: Resumes must demonstrated experience with Life Sciences Manufacturing. Know of and experience with FMEA, PDUFA v, GAMP 5, ITIL, Risk based assessments Expertise in IT Quality assessments and regulatory/compliance standards Experience in delivering materials to global audience Experience in development of enterprise wide process, policies, procedures and templates Ability to work with both IT and Quality senior leadership Has proven creditability in the regulatory sector Hands on ability to create materials from standard MS Office applications Ability to run workshops Proven regulatory IT Quality Assurance experience and sector presence First box above are REQUIRED skills, box below are PLUS/Nice to Have skills Description: Drive the creation of enterprise-wide IT Quality assessment processes, policies and procedures using variety of industry based standard approaches such as FMEA, GAMP 5, Benefit-Risk templates, etc. This position would be a Senior position to provide expertise to assist me with a global IT response to a recent FDA Audit. There would be multiple project teams working on deliverables, including integrated risk assessments. I need someone who understands IT Quality/Compliance, can help me manage the governance of the program including multiple deliverables, communication planning/delivery to both Sr. IT and Quality audiences. This person would utilize their expertise to define companywide standards for IT in relation to Integrated Risk Management and Global Deployment best practices utilizing standards such as GAMP and ITIL. They would provide expertise on risk evaluation techniques such as FMEA, etc. They would help establish the various teams and define their responsibilities. There may be occasions where this person might actually help a team drive to results. With PM support, they need to assure the program tracks to schedules, mitigates issues and reports dashboard updates. Regards, Abid Hassan | Staffing Manager | abid.has...@panzersolutions.com | Panzer Solutions LLC. | 45 Stuart Ave • K Unit • Norwalk, CT • 06850 |Fax: 203-286-1457 | 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 "SAP or Oracle Financials" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to sap-or-oracle-financials@googlegroups.com. Visit this group at http://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/d/optout.
