Seeking a senior position in IT Validation, Quality and Compliance which utilizes my technical and organizational skills in a developing and challenging environment. Responsible to apply the specifications of the corporate and organizational Quality Systems and Quality standards to ensure that the quality of processes and deliverables of both projects and services continuously meet their specified corporate and regulatory requirements. 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. 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. In-depth knowledge of validation, quality Management, quality assurance, documentation, equipment validation, Facilities, SIP, CIP, vendor auditing and product improvement. Demonstrated success in interviewing user organization to gather understanding of needs and requirements. Responsible to build SOPs, WIs, Operations Manual within regulated environments for GxP systems in order to maintain systems in validated state. Responsible for the validation of IT-Shop Floor applications, Infrastructure Systems & Quality systems like Application Server, Enterprise Backup Server and Cognos reporting System. Lead all IT Infrastructure Qualification projects including Databases, Network Operations, Storage and Backup Services. Supports ongoing change management for GLP systems in conjunction with the IT Business Partner and GLP system owners as required by company procedures. Reviews and approves change requests based on risk / business need. 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. Full Validation life cycle experience including developing and maintaining Validation Plans (VPs), Validation Scripts, and preparing Validation Summary Reports. 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 in JIRA based application and provide assistance in the execution of changes for GxP systems. Developed Quality Control Systems to ensure proper tracking of documentation in conjunction with FDA requirements. 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, cGCP , cGAMP, cGLP, and developing IQ, OQ, PQ, VMP, VLC, VSD, 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. Managed validation activities for medium to large projects for multiple sites globally. Perform other duties as assigned.
