Information Governance Management (IGM) Manager / Sr. Quality Manager Resume Example

Seeking a senior position in IT Validation, Quality and Compliance which utilizes my technical and organizational skills in a developing and challenging environment. Accomplished CSV IT QA professional with 9+ years of progressive experience and proven record of significant, successful contribution in Computer System Validation (CSV), Quality Management, Project Management, Process Improvement, SDLC, Standards and Systems in a wide range of regulated (GxP) organizations. Lead team of internal employees and external 3rd party resources for global GxP projects. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements. Self-motivated, highly organized with superior leadership qualities. Managed CSV activities for medium to large complex projects for multiple sites globally. Ability to interact across all levels of the IT organization along with demonstrated success in a "matrix" type environment. Responsible to work with senior management and line function heads to define road map for projects within the GxP Organization. Manage and advise on critical GxP compliance and quality issues. Work closely with Quality Assurance team to ensure the GxP systems are in compliant with Regulatory Requirements. Plan and manage GxP projects; prepare and maintain accurate records; analyze; manage budget and cost control. Responsible for providing GxP and CSV training to IT Organization within regulated industries. In-depth knowledge of Validation, Quality Management, Quality Assurance, Documentation, Equipment Validation, Facilities, SIP, CIP, Vendor Auditing and Product Improvement. Responsible to build full Validation life cycle experience including developing and maintaining Validation Plans (VPs), Validation Scripts, and preparing Validation Summary Reports. Responsible to create SOPs, WIs, Operations Manual within regulated environments for GxP systems in order to maintain systems in validated state. Responsible for auditing CSV deliverables and assist QA during the FDA audits. Responsible for the validation of IT-Shop Floor applications, Infrastructure Systems & Quality systems like Application Server, Enterprise Backup Server and Cognos reporting System in both GMP and GLP environments. Lead all IT Infrastructure Qualification projects including Databases, Network Operations, Middleware, Storage & Backup Services and provide support to AWS cloud qualification. Experienced in validating custom built applications and COTS systems. Experienced in documenting all phases of system life cycle as required by FDA regulations. Track record for providing definitive compliance technical expertise for Manufacturing, Lab and Quality software, hardware and instrument related projects including acting as Subject Matter Expert on 21 CFR Part 11/Annex11. Create and execute validation plans to document all phases of the system life cycle as required by FDA regulations and GxP documentation standards for finished pharmaceuticals. Developed and implemented successful corporate programs (including authoring quality documentation) to improve quality control and quality assurance throughout Software Development Life Cycle (SDLC). Manage Change Control Requests and provide assistance in the execution of changes for GxP systems. Health Authority Regulations: Food and Drug Administration (FDA) regulations: FDA 21 CFR Part 11: Electronic Records; Electronic Signatures; Final Rule; August 20th, 1997, Part 210 (cGMP in manufacturing, processing, packaging and holding of goods), Part 211 (cGMP for Finished Pharmaceuticals), Part 810 (Medical Device Revise Authority), and Part 820 (Quality System Regulation) Swiss Medic: Swiss Ordinance relating to Good Laboratory Practice (GLP), adopted May 18th, 2005 [RS 813.112.1]. This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C(97) 186/Final]. Experience in cGxP environments like cGMP, cGAMP, GCP, cGLP, and developing MVP, VPs, IQ, OQ, PQ, URS, FRS, TM, VSR and SOPs. Good skills in Computer System Validation (CSV). Excellent written and verbal communication skills. Ability to work individually or as a part of a team. Experienced as team resource and individual contributor. Perform other duties as assigned.

Quantitative Structure Activity Relationship (QSAR) studies of Anti-HIV-1 ritonavir analogues. Raghava C. Kasara, Barun Bhhatarai and Rajni Garg, 232nd American Chemical Society National Meeting San Francisco, CA, September 10-14, 2006. *Pharmacokinetic modeling of anti-HIV protease ritonavir analogues. Raghava C. Kasara, Barun Bhhatarai and Rajni Garg, 233rd American Chemical Society National Meeting Chicago, IL, March 25-29, 2007. *Pharmacodynamic modeling of C2 symmetric HIV-1 protease inhibitors. Raghava C. Kasara and Rajni Garg, 234th American Chemical Society National Meeting Boston, MA, August 19-23 2007.

21 CFR Part 11, Business Analyst, change management, Chemistry, Hardware, continuous improvement, DDS, Data Migration, delivery, documentation, Functional, GMP, GLP, Information Security, IQ, LAN, regulatory compliance, Managing, meetings, Access, Microsoft Visio, Navigator, Network, organizational, Personnel, processes, progress, protocols, Quality, Quality Management, Quality Assurance, Requirement, SOP, Specification, system documentation, teaching, Training materials, UML, Validation, workflow