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Online Resumes with "EU Regulations"



analytical laboratory manager

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...

Tags for this Online Resume: QA/QC analytical manager, FDA ICH, operations manager, laboratory setup, laboratory organization

QA Manager, document Control

I have over 30 years of experience in the medical device, pharmaceutical, and biologics experience with a strong background in Class III Medical Device Safety and pharmaceutical quality and compliance. My management background included coordinating inspection assignments, managing investigation activities and assigning investigation tasks to all involved departments, preparing summary reports, reporting metrics for complain...

Pharmaceutical/Biotech Quality, Compliance Director

I am available immediately & looking for a new opportunity. I am passionate and dedicated to the continuous improvement philosophy. My qualifications: Senior level cross-functional team management experience in GMP pharmaceutical, & biotech industries; thorough knowledge of current FDA & EU regulations and guidelines; well-organized, excellent communication & interpersonal skills, analytical problem solver; CAPA solutions,...

Tags for this Online Resume: Senior Executive, Pharmaceutical/Biotech, Quality, Compliance, FDA Regulations

Clinical Quality Assurance - 15 Years of Experience - Near 27502

Tags for this Online Resume: Root Cause Analysis, ISO, Corrective Actions, Management, Policies and Procedures, Process Improvement, Quality Assurance, CAPA, Quality, Manufacturing, cGMP, CFR 21, Teamwork, Auditing, Deviation Management, SPE, ASQ CQIA, Calibration/Validation, Product Release, Direct observations, Training, MS Suites, EU Regulations, CLIA

Featured Profile

Clinical Regulatory Affairs - 20 Years of Experience - Near 53143

Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...

Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices

Chemist - 20 Years of Experience - Near 84341

Areas of Expertise * Batch Record Review * Transfer of Analytical Data (TAP) * GMP & Regulatory Affairs * Remediation * Process Validation * Deviation Resolution * Lab Environmental * CAPA Investigation * Quality Compliance & Assurance * Product Quality Management * Manufacturing of Sterile and aseptic products * 21 CFR, EU Regulations, and ISO 13485 * Safety and Regulatory Compliance * HPLC for API and Finished Product usi...

Tags for this Online Resume: Manufacturing, Pharmaceutical, High Performance Liquid Chromatography (HPLC), Management, Pharmaceutical Industry, Research and Development, Regulatory Affairs, API, Application Program Interface

Quality Coordinator - 5 Years of Experience - Near 08817

PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...

Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting

Chief Operations Officer

SUMMARY OF QUALIFICATIONS Extremely dedicated and detail-oriented professional with an extensive record of improving operations in the trucking industry to achieve unprecedented cost-efficiency utilizing proven expertise in the following areas: Areas of Expertise * Cargo Loss Prevention * Cargo Theft Prevention * Crisis Management * Risk Management * Team Building & Training * DOT Compliance * OSHA Compliance * Safety Compl...

Ideal Companies: Consultant

Tags for this Online Resume: Compensation, Distribution, Occupational Safety and Health Act, OSHA, Compliance, Safety Equipment, Training, Security, Microsoft Internet Explorer, Pharmaceutical Industry

President - 0 Years of Experience - Near 21804

SUMMARY OF QUALIFICATIONS Extremely dedicated and detail-oriented professional with an extensive record of improving operations in the trucking industry to achieve unprecedented cost-efficiency utilizing proven expertise in the following areas: Areas of Expertise * Cargo Loss Prevention * Cargo Theft Prevention * Crisis Management * Risk Management * Team Building & Training * DOT Compliance * OSHA Compliance * Safety Compl...

Tags for this Online Resume: Compensation, Distribution, Occupational Safety and Health Act, OSHA, Compliance, Safety Equipment, Training, Security, Microsoft Internet Explorer, Pharmaceutical Industry, management, manager, Consultant, Transporation Managment, Violation, Logistics Managment, Quality Assurance, Transportation Consultant, Violation Consultant, Quality Assurance Consultant, Logistics Consultant

Featured Profile

Pharma/Drug Safety (Research, Development)

Highly experienced, trained research and drug safety professional with extensive knowledge of FDA, EU and ICH regulations necessary to develop, study, and market medical drugs and devices. Public health professional with over 15 years of proven experience as a general physician, direct outpatient care and emergency medicine provider. Passionate about global health and drug safety. Adept in research, grant writing, public he...

Ideal Companies: Abbott, Medix, PRA health sciences, Catawba Research, Medpace, Acelity, Bellicum Pharmaceuticals, Covance, US Prahs, Novartis, Bayer, Integrated Resources INC, The University of Texas Sothwestern, Baylor Scott & White Health, Abbvie

Tags for this Online Resume: Public Health, Clinical Research, Data Analysis, Pharmacovigilance, FDA regulations, drug/device research and development, clinical trials, risk management, regulatory compliance, French language, Spanish language