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Online Resumes with "PQ"
Director
SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...
Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices
Department Manager - 3 Years of Experience - Near 13485
SUMMARY Management / Leadership: Lead diverse teams consisting of Engineering, Production, Design and Raw Materials personnel, organized support functions such as Warehousing, Sourcing, QA/QC, Planning and Maintenance, drove superior results through continuous process improvement and leveraged technological innovations. Direct supervision of up to 25 people in 24/7 production environment. Extensive experience as a Project M...
Tags for this Online Resume: Project Management, Project Manager, Pharmaceutical, Process Improvements, Reliability, Management, Applications, Fabrication, Risk Assessment, Manufacturing, Validation, Food & Beverage, Chemical Engineer, Fermentation, Extraction, Distillation, Continuous Improvement, Cell Culture
Program/Project Manager
Highly skilled innovated mechanical engineer with proven track record of achievement in design, manufacturing, project and program management experience with international Fortune 500 companies. Pragmatic Manager who specializing in driving companies to capture, growth and sustain profitably and market share. Provides vision and strategies to transforms corporate initiatives and projects to lucrative realities Expert in mec...
Ideal Companies: General Atomics, illumina, Sony
Tags for this Online Resume: LeanManufacturing, Project Management, Quality Assurance, Technology Transfer, Consumer Electronics, Biomedical, GD&T, Process Improvement, Mechanical Design, SolidWorks, Program Management, New Product Introduction, Manufacturing Engineering
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Quality Assurance Specialist - 15 Years of Experience
AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV)/Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance. * Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation proto...
Tags for this Online Resume: Compliance, Test, Test Cases, Automation, Documentation, Protocol, Risk Assessment, Business Requirements, SAS, Test Plan
Industrial Engineer - 3 Years of Experience - Near 10453
Profile Industrial Engineer with strong experience advanced product quality planning (AQPP). Experience in validation protocols (IQ/OQ/PQ/CSV), data analysis, quality and process reports, regulatory compliance from defect detection & rejection and documentation. Detail-oriented professional with lean six sigma, 5-s, value stream mapping, scheduling, process improvement, and continuous improvement efforts, layouts, data anal...
Tags for this Online Resume: Manufacturing, Quality, Quality Assurance, Medical, Collection, Complaints, Compliance, Corrective Actions, Data Analysis, Documentation
Quality Manager - 20 Years Experience - Tijuana BC Mexico
SUMMARY Professional with over 19+ years of experience in large world-class multinational companies, medical, automotive and metalmechanic industries, Electronics EMS. An accomplished Quality Professional with solid and extensive background in Quality. Dynamic leadership skills and complex problem-solving abilities. Experienced communicator with practical execution of Six-Sigma, FMEA, APQP, PPAP, SPC, DOE, IQ, PQ, OQ, FAIR ...
Tags for this Online Resume: Automotive, Customer Service, Manufacturing, Quality, Quality Assurance, Quality Control, Test, Internal audit, PPAP, Audit, ISO 9001, ISO/TS 16949, ISO13485, AS9100, IQ,PQ,OQ
Mechanical Engineer - 13 Years of Experience - Near 46037
To seek a position in a work environment that rewards performance while contributing to the growth and success of the organization. To obtain a position that will provide the ability to apply my management/leadership skills, communication and relationship skills, my ability to lead by example while mentoring employees and encourage individual growth, to meet project objectives and deliverables while maintaining a productive...
Tags for this Online Resume: plastic injection molding, Project Manager, Mechanical Engineering, SAP, Validation/Verification Testing, Project Leader, Manufacturing, GD&T, electronic packaging, IQ/OQ/PQ, Michigan, FDA, ERP, Supplier Relationship, RFQ, MS Project, DFMEA & PFMEA, Pro Engineer
Quality Manager - 20 Years of Experience
Summary Over 20 years' experience in a medical device industry. Out of the box thinker who is self-managed, self-motivated, results oriented, quality conscious, problem solver, with ability to multi-task, make decisions, resolve issues, meet deadlines learn new skills and communicate effectively at all levels of the business. Experienced in the following: Receiving Inspection, Final inspection, internal auditing and supplie...
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Angioplasty, Internal Auditor, Good Manufacturing Practices, Manufacturing, Project Coordinator, Test, Green Belt
Clinical Data Management - 1 Years of Experience - Near 02176
SUMMARY: 4 years of experience in working with both Sponsor and CRO industry focusing on computer systems validation, query management and clinical data management documentation. Worked on creating and handling validation master plan, data management plan, case report forms, change control and data validation specifications. Experience in validation of software's of clinical trial databases, ePRO-electronic patient reported...
Tags for this Online Resume: Documentation, CFR Part 11, Management, Test, Test Scripts, Data Management, Hematology, User Acceptance Testing, Acceptance Testing, Change Control
Engineer - 20 Years of Experience
SUMMARY: Hands-on, Multidisciplinary Design Engineer with Project Management and NPI/NPD experience. Electrical, Mechanical, Electromechanical, Controls, Process, and Lean Manufacturing Systems Design, Development, Commissioning and Optimization. * Purpose Built Machinery Design, Development, and Automation for Manufacturing, Assembly, Packaging and Test. Design Specification to Installation and Commissioning, IQ/OQ/PQ (Pro...
Tags for this Online Resume: Electronics, Control Systems, Manufacturing, NEC, Power Distribution, Reliability, Troubleshooting, UL, IEC 60601, Systems Design
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical