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Online Resumes with "MHRA"
Clinical Research/Pharmacovigilance - 3 Years of Experience - Near 10001
Current MPH Student in Epidemiology at Columbia University, PhD in Biological Sciences, experienced in Clinical Research Development & Management, Pharmacovigilance and Health Information Technology.
Tags for this Online Resume: SAS, Clinical Research, ICH-GCP, FDA/EMEA/MHRA, Drug Safety, Study Design, New York
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Process Engineer - 19 Years of Experience - Near 41105
Hi, Referring to your advt post on ISPE for the position Director, Process Engineering, I am Shailesh; completed Masters in Process Design from one of Premier Inst. in India (Indian Inst. of Technology- Delhi) . Currently working with Biopharmax Ltd , since Sept 2015 as a General Manager (Design) handled- projects and Engineering Services in capacity of from 5Mn. to 55 Mn. USD.(Process & Infra. Projects) mostly for Joi...
Tags for this Online Resume: Pharma, API, and Biotechnology , Project Management, facility design, detailing, Pharma formulation and API unit Machinery, system, , USFDA, ANVISA, MHRA , Techno-commercial negotiations for terms sheets, contracts , Process scale-up, Bioreactor design, Project Management tools-MSP
Pharmaceutical Quality Assurance Specialist- 10 years Experince- Atlanta
Seeking a challenging assignment in Quality Assurance in the pharmaceutical sector to utilize acquired expertise and deliver best-in-class results. PROFESSIONAL SNAPSHOT: •A Quality Assurance Professional bestowed with 10+ years of experience in Corporate Quality Assurance, Plant Quality Assurance, Manufacturing, Validation and different International Quality audits in Solid Dosage. •Hands on experience with Quality Manage...
Tags for this Online Resume: QMS, Batch Record Review, Preparation of SOP, CAPA, Investigation, Change Control, Deviation, Internal Audit, Document Control, Batch Release, Solid Dosage, Process Validation, APQR, Market Complaint, GMP, OOS, Self Inspection, Third Party Audit
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Clinical Quality Assurance - 20 Years of Experience - Near 60559
SUMMARY Acting Site Head Quality for XELLIA Pharmaceuticals - Facility was under Consent Decree-FDA Director Global Quality Ops-Tech Services Injectable Vertical, in Bangalore INDIA, MYLAN Inc. Director Validation & Tech Services, MGP a Wockhardt, Ltd, company. Built for the Aseptic Filling, Formulation Equipments and Computer Systems and IT-Automated Systems in RM. SME in FDA, TGA, EMA/MHRA Audits for Tech Transfer and Hos...
Tags for this Online Resume: BMS, CMOS, Siemens, Apollo, Assembly Line, Insulin, Management, Program Manager, Project Management, Quality, QA/QC CSV
Microbiologist - 6 Years of Experience
Qualifications of equipment's. * Analyst qualifications. * On the Job training. * Testing method validation. MAJOR AUDITS FACED: USFDA, TGA, MHRA, ANVISA (Brazil), UKRAINE, GSK, NHL, W.H.O, DRUG CONTROLLER AUDIT. VALIDATION EXPOSURE: * Media fill validation * Antibiotic bio assay * Excel sheet validation for calculations. * Sterility method validation * Bioburden method validation * Microbial Enumeration Test * Bacterial En...
Tags for this Online Resume: Microbiology, Quality, Quality Assurance, Quality Control, Distribution, Test, Training, Audit, Communication Skills, English Language
Quality Manager - 14 Years of Experience - Near 00969
Summary of Qualification Electrical Engineer with broad experience in the Electronic, Electro Mechanic and Pharmaceutical Industries. Green Belt and ASQ-CQE Certified, Black Belt Trained. Strong knowledge on CFR, Aseptic Pharmaceutical Manufacturing Process and cGMP. Managed major document types as Annual Product Quality reports (APQRs), Master Batch Records (MBRs), Standard Operational Procedure (SOPs), Stability Studies a...
Tags for this Online Resume: Quality and Compliance, Audit, Budgeting, GMP, REgulatory, Data Management, Documentation, Fabrication, KPI metrics, Leadership, Management, Change Control
Operations Manager - 20 Years of Experience - Near 21120
SUMMARY OF EXPERIENCE: Results-driven Pharmaceutical Manufacturing and Technology Transfer professional with over 27 years' experience in global pharmaceutical (Ethical and Generic) and personal-care companies. Managed operating efficiencies and quality through strategic planning, partnering, teamwork, and effective problem solving techniques in plant operations that generated significant improvements. Effectively leveraged...
Tags for this Online Resume: Pharmaceutical, Management, Documentation, Medical, Medical Terminology, Occupational Safety and Health Act, OSHA, Pharmacology, Science, Chemistry
Technical Manager in Manufacturing- 11 Years of Experience - Near Salt Lake City, UT
Seeking Operations or Sr. Engineering Manager position. Methodical, innovative, and results-driven leader with hands-on experience in regulated and non-regulated industries, focusing on strategic planning and operational excellence. Effective at developing and implementing strategies to attain set-forth business key performance indicators (KPIs), maximize growth opportunities, and streamline processes and company operations...
Tags for this Online Resume: Manufacturing, Reliability, Process Improvement, Instrumentation, Matlab, Troubleshooting, Complaints, Data Analysis, Diagnostic Tools, Ethernet
Materials Scientist - 6 Years of Experience
Aspire to develop innovative products including Ironic Liposome and Magnetic Belt for Cancer treatment, speedy growing epithelial cells for quick healing of wounds and Mosquito eradicators statue to make mosquito free city by reaching the position as Sr. Principal Scientist Formulation- Research and Development.
Tags for this Online Resume: formulation Scientist, GMP,cGMP, GLP,cGLP, USFDA,FDA, MHRA,TGA, Stability enhancement, Coating , Dissolusion enhancement, Powder, Tablet, Capsule, Pelltes
Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440
Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...
Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality
