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Online Resumes with "Process Validation "
Experienced Quality Assurance Engineer with 10 years of experience in quality related areas, including QA, QC, compliance audits, program management and process development in the electronics industry. Skilled at working with and facilitating cross functional teams, including sales departments. Excellent negotiation, teaching and people management skills. A responsible, independent, fast learner who is a results oriented t...
Tags for this Online Resume: Quality Assurance
With my extensive experience in working for a global IT organization, I have demonstrated the ability to deliver strong customer service and support skills with detailed Asset Inventory administrative know-how which I want to continue as follows: Liaison between clients, suppliers, colleagues, and management which gives me the ability to work proactively in inventory management processes, and offer solutions to any probl...
To use my skills as a process/cleaning validation specialist for an upward moving pharmaceutical company
I’m looking for opportunities where I can mix the hands-on work with process troubleshooting/optimization in combination of managing of a product/project from the decision-making level regarding capital projects, project direction, etc. I have worked on all facets in the lifecycle of a process/product from the R&D side in its development and optimization coming into a fully validated manufacturing process and then supporti...
Over five years of diverse validation experience in the Pharmaceutical industry. Enthusiastic, ingenious, and results oriented professional. Highly effective in teamwork environment. Oriented towards resolution of problems. Knowledge of principal and supplemental FDA Regulatory Guidelines like: Solid Dosage Blend Uniformity, Dissolution Guideline, Stability Guidelines, cGMP, Conformance Standards, SUPAC and SOP’s. Expe...
Technical Specialist with a wide range of expertise in Quality, Operations, and Compliance within the Pharmaceutical and Medical Device Industry. Expertise in the manufacturing arena including Technical Support, R/D, Process Validation, IQ/OQ, Quality Assurance, and Quality Engineering. Other knowledge include assay development and scheduling.
I have a hands-on experience interacting with suppliers, internal customers, and subject matter experts to ensure thorough evaluation and accuracy of discrepancies and investigations, identifying root cause, coordinating corrective and preventive action plans, writing summaries, and reviewing reference documents. I am experienced in change control process for externally initiated material changes in accordance with cGMP, U...
Extensive experience in developing manufacturing processes, work instructions, fixture design and Lean Manufacturing Practices.
Tags for this Online Resume: Manufacturing Processes, Work Instructions, Fixture Design, Lean Manufacturing, Cost Reduction, Six Sigma, Kaizen, Root Cause Analysis, Failure Investigations, High Performance Documentation, Training, Design for Manufacturability, New Product Introduction
Monitored and adjusted control levels in a manufacturing environment to produce the highest purities of industrial gases. Led all process validation, instrument calibration and qualification projects
Tags for this Online Resume: quality testing, process instructions, process validations , troubleshot production issues (CAPA’s) , AutoCAD, Solid Works, MS Office Suite, , RF welding, filling, packaging
Wide scope and technical depth in Development or Manufacturing Operations for Pharmaceutical/ Biotech Organization