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Online Resumes with "c GMP"
Production Supervisor
SUMMARY: * More than 21 years of excellent experience in Medical Device & Pharmaceutical companies in the area of Process engineering, process Validations, Equipments Qualifications (IQ/OQ/PQ), Process Development Cleaning Validations, New Product Developments, Product and process Technology transfer, Troubleshooting Processes, and in Medical Devices, Product Testing. * Extensive experience in Quality assurances: Auditing, ...
Tags for this Online Resume: Risk Assessment, Quality, Audit, Corrective Actions, Management, Process Improvement, Technology Transfer, Training, Change Control, Good Manufacturing Practices
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Quality and Regulatory Compliance
SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...
Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services
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
Scientist - 15 Years of Experience - Near 30045
PROFESSIONAL SUMMARY * Result oriented, Creative, Passionate, highly focused, experienced Pharmaceutical R&D Scientific Lead with good ethics, possessing over 15 years of experience in Formulation design, Process Development, Optimization and Scale up of various Pharmaceutical Dosage Forms, Solid Orals (IR and ER Tablets and Capsules), Liquid Orals (Solutions, Syrups and IR / ER Oral suspensions), and Parenteral formulation...
Tags for this Online Resume: Product Development, Filing, Pharmaceuticals (Generics), Formulation Research, Management, Budgetary, Process development, Oral solid dosage forms, Manufacturing, ANDAs
Department Manager - 20 Years of Experience - Near 92128
Areas of Expertise * Business Process Improvement * Environmental Monitoring * Inventory Control & Management * Production Planning & Scheduling * Strategic Planning & Implementation * Process Design & Validation * GMP and ISO 13485 Compliance Recruited to establish Production Reva Medical San Diego, CA Established and directed formal operations functions supporting production of pre-clinical and clinical supplies collabore...
Tags for this Online Resume: Automation, Hazardous Waste, Instrumentation, Integrate, Metrics, Order Processing, Process Improvement, Production Metrics, Management, Good Manufacturing Practices
Not Listed - 13 Years of Experience - Near 10956
SUMMARY An accomplished, charismatic and energetic leader with over 20 years progressive experience in multiple regulated industries. Expertise in Regulatory Compliance, Supplier Quality, Quality Assurance, Quality Control, domestic US cGMP (QSR) and international Quality Management System (QMS) implementation and/or improvement. Experience with US and European Regulatory Agencies and an expert facilitator for FDA and other...
Tags for this Online Resume: New Jersey, Management, people management, Facilitator, Internal audit, ISO, FDA, LMS, MDR, Supplier Quality, Quality Assurance, QMS, Validation, Quality Agreement, CAPA, QSR, cGMP
Supply Chain Manager
Areas Of Expertise Warehousing & Distribution Management ( Ecommerce/Drop Ship ( Palletizing Pick/Pack Textiles ( Inventory Control & Optimization ( Supply Chain ( Truck Dispatching/DOT Manufacturing & Production Management ( Scheduling/Home Delivery ( Vendor & Customer Relations ( Project Management ( SAP/ERP ( Budgeting & Financial Reporting ( OSHA, FDA & Safety Regulations ( Forklift Certified/Trainer ( Team Development ...
Tags for this Online Resume: Pharmaceutical, Budgeting, Distribution, Inventory, Inventory Control, 3PL, ASN, Ecommerce, EDI, Electronic Data Interchange
Facilities Manager - 18 Years of Experience
SUMMARY A detail-oriented and dynamic operations management professional, with a proven track record of success in project management, effectively and efficiently planning and executing installations, relocations, and vendor selections. Possesses extensive experience in all facets of facility direction, development, coordination, and management, including shipping and receiving, building services for cGMP laboratory operati...
Tags for this Online Resume: HVAC, Management, Planning, Project Management, Training, Utilities, Architect, Managed Security, Manufacturing, Noise
Quality Engineer - 10 Years of Experience - Near 00782
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio,...
Tags for this Online Resume: Manufacturing, Documentation, Quality Assurance, CAPA, Audit, Complaints, Investigations, Good Manufacturing Practices, Internal audit, Management, Systems
Supply Chain Manager
CAREER SUMMARY Professional background includes more than 25 years of increasingly more responsibility and diverse experience in a Manufacturing/Corporate environment. Expertise in all aspects of Supply Chain management encompassing activities involved in the sourcing, procurement, conversion and logistics of product from point of origin to point of consumption. Worked collaboratively both domestically and globally in a mat...
Tags for this Online Resume: Pennsylvania, New Jersey, Pharmaceutical Industry, Manaagement, cGMP knowledge, Supply Chain
Protein Purification Process Development /GMP Scientist
To attain employment within the Biotech / Biopharma industry in the Greater Boston area where my unique blend of knowledge and experience can combine with my work ethics, commitment and dedication to significantly increase your organization’s growth, profitability and efficiencies.
Tags for this Online Resume: protein, cGMP, process development, assay development
