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Online Resumes with "TracKWise"
Chemist - 15 Years of Experience - Near 03811
Tags for this Online Resume: Trackwise, CAPA, Deviations, Regulatory Inspections, Audits, SOP Documentation, GMP, Compliance
Chemist - 20 Years of Experience - Near 92656
Chemist with extensive experience in the pharmaceutical, oil and cosmetic industries. Quality assurance in manufacturing environment. AREAS OF EXPERTISE • Proficient in c’GMP, Analytical chemistry, Quality Assurance • Stability testing, analytical method validation, quality control (QC) and other laboratory activities within ICH and FDA compliance guidelines • Empower, Chromeleon, Chem-Station, Nugenesis, Trackwise, Ele...
Tags for this Online Resume: RD, HPLC, UPLC, Empower, CHROMELEON, CHEMSTATION, Method Validation, Stability
Business Analyst - 7 Years of Experience
With over 7+ years of experience in Pharmaceutical Manufacturing - I.T, I have understanding of the Laboratory Information Management Systems (LIMS) and it’s interfacing with other Systems such as ERP, Trackwise etc. I am eager to work in Business Analyst Role to explore my capabilities.
Tags for this Online Resume: Business Analyst, Pharma Manufacturing, LIMS
Compliance Manager - 18 Years of Experience - Near 92128
A Quality Assurance and Regulatory Compliance leader with over 17 years of hands-on experience in Class I, II and Class III cardiovascular medical devices (implantable defibrillators), disposable products, patient monitoring devices, mobile medical devices/apps and combination drug/device products. Held various positions with increasing authority and responsibilities in management and functions which have led to comprehen...
Tags for this Online Resume: Quality Assurance / Operations , CAPA Management , Process Engineering , Change Control , Internal / External Audits , Lean /Six Sigma, Quality System management, Complaint management
Quality Engineer - 12 Years of Experience - Near Overland Park, KS
To work for a company where Quality is taken seriously, and, when one is hired to ensure product quality, one is truly expected to ensure such. Any company I work for must strive for continuous improvement and efficiency and not let, ironically, bureaucracy and red-tape interfere with the accomplishment of these improvements.
Tags for this Online Resume: trackwise, compliance suite , compliancesuite, microsoft office, microsoft access, mcclaren MCDS, pharmaceuticals, quality assurance
MBA Grad
Tags for this Online Resume: MS Office, JD Edwards, Trackwise, LIMs
Quality & compliance professional with 24 yrs of experience
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809
Quality Engineer - 14 Years of Experience - Near 91016
Over14 years of in-depth experience in the pharmaceutical industry. Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes. Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...
Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation
Document Management - 20 Years of Experience -New Jersey
Tags for this Online Resume: documentation, quality control, quality assurance, midas, trackwise
Quality Reviewer - 3 Years of Experience - Near 27278
Tags for this Online Resume: Durham, SAP, Trackwise, RTP, Smart, Dedicated , Honest, Hard working
Clinical Quality Assurance - 15 Years of Experience - Near 27520
Grifols Quality Associate III- Review and audit batch production records Nov. 2008 - present * Review laboratory testing records for accuracy Follow Standard Operating Procedures * Prepare batch paperwork for final release of product Works in a cGMP environment where FDA21 CFR Part 11 210 and 211 laws are followed Use of specific databases such as SQL LIMS SAP Trackside EDMS document control system
Tags for this Online Resume: Quality , audit, LIMS, SAP, Europe, ISO 14001, Trackwise, Structured Query Language, Audit, Documentation, Kaizen, Support, Microsoft, Microsoft Office, Cardiopulmonary resuscitation (CPR), Structured Query Language, Audit, Documentation, Kaizen, Support, Microsoft, Microsoft Office, Cardiopulmonary resuscitation (CPR)
Chemist - 15 Years of Experience - Near 07747
SUMMARY OF FUNCTIONAL EXPERIENCE AT AKORN: Hands-on experience with pharmaceutical analysis using HPLC, GC/HS, Spectroscopy, physical and wet chemistry. Familiarity with Analytical Chromatography software Backman Peak-Pro, Perkin Elmer TotalChrom and recently implemented Thermo Fisher Chromeleon. Trackwise software for OOS, OOT and deviation investigation. iStability software for stability monitoring and trending. * Quality...
Tags for this Online Resume: Pharmaceutical, Pharmaceutical Industry, Quality Control Chemistry, Quality Control Chemistry, Quality Control, Accredited Pension Representative, Audit, QC Manager
