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Online Resumes with "Validation Plans"
I have been in Management and Director positions. As a Senior employee I can provide much experence to any company.
Ideal Companies: Small to Mid size Pharmaceutical or Medical Device company
Started as a research assistant for a company that markets specialty clay for additives in polymers. Was listed as inventor on three patents. After a short assignment at a food company, moved into validation and quality work in the pharmaceutical industry.
I am a Business Analyst with over 10 years experience in a clinical trials environment. I have excellent requirements gathering and documentation experience as well as experience in testing and training. I am looking for a company in which I can grow and stay. I was with my last company for over 16 years. I would like to remain in the healthcare arena if possible, but am open to other industries.
Implemented knowledge of ICH GCP and CDISC Standards. Proven organizational skills with the ability to learn quickly; excellent time management, meet tight deadlines; manage multiple tasks and changing priorities while working in a high-pressured environment. Reputable for my attention to detail skills and strong ability to respond and solve problems in real time to fulfill customer expectations. Ability to work effectively...
I live in Atlanta and trying to make a move to Cleveland OH. I have lots of experience and skills that I would like to offer to the Company that takes me on. High energy IT professional with exceptional interpersonal, communication and leadership skills. Resourceful, creative, loyal, and Dedicated.
Promote compliance with all GLP regulations, including IACUC and internal policies, procedures, state and federal regulations. Audited complex systems, facilities, study protocols, validation plans, raw data, in-life critical phases and final reports in the ABSL-2, 3 and 4.
My skills in R&D and cGMP experiences with the following analytical techniques; HPLC (Agilent & Waters, using Empower), GC (Agilent & Perking Elmer), ICP-OES (Perkin Elmer), Dissolution and other analytical test. I am currently working on large molecules (cIEF), troubleshooting methods and instrumentation problems; developing and executing validation plans; carrying out method transfers; and method development.
Interfaced Johnson Controls to Allen Bradley PLC Pharmaceutical control system. Designed to commercial and military test specifications, including interface requirements, test flow and strategy, measurement accuracy, and acceptance criteria. Experienced with product thermal analysis, signal integrity analysis, verification, qualification, and validation requirements. Performed Bit Error Rate Test (BERT) analysis on differen...
Hi, I am a Certified PMP and MBA in Operations Management with 10 years experience in IT software consulting. My previous experience has been focused on: • Direct interaction with customers and Business users at On-Site customer locations, working on requirements gathering, solution design, solutions enhancements and change management. • Project plan and estimation, work breakdown, delegation of responsibilities to team me...
Resourceful professional with extensive experience in systems engineering/integration with expertise in all aspects of rocket/spacecraft technology, including dynamics, propulsion, flight control and sciences, software, design reviews, mass properties, and test equipment. Well versed in requirements development, definition, integration, analysis, configuration, documentation, and change control. Track record for providing e...
Ideal Companies: Aerospace defense missile rocket guidance GN&C ground space payload integration flight avionics launch systems FMECA hardware analysis
Luis A. Jiménez Silva Tel. (787) - 653-6759 Home or Mobile 787-662-5229 E-Mail: email@example.com Skype ID: luis_jimenez_silva111 OBJECTIVE: I am seeking a challenging and opportunity position in Quality System Manage...
Tags for this Online Resume: validation, validation specialist, commissioning, mechanical engineer, relocation assistance, construction QC field inspector, P&IDs As Built verification inspection/documentation, Change Order Requests, pharmaceutical, medical devices, CSV, IQ/OQ/PQ, SOP, User Requirements Spec. (URS), Functional Requirements Spec. (FRS), System Design Specs. (SDS), Traceability Matrix, cGMPs, Technical writing, Change Proposals documentation, implementation, and closing, Failure Mode Analysis, Gap Failure Analysis, Validation Plans