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Online Resumes with "Regulatory Inspection"



Security Manager - 30 Years Experience

Effectively use thirty plus years of nuclear industry and military experience to help improve and lead an organization to operational and financial excellence. Ensure compliance while simultaneously enhancing organizational effectiveness. Achieve quality sustainable results while balancing company goals and business relationships. Honor the principles and practices of facilitative leadership to maintain a healthy culture an...

Quality Coordinator - 0 Years of Experience

Summary: * Extensive experience in clinical data management, pharmaceutical, and device research industries. * Experience working with Adverse Event Reporting and Medical Device Reporting. * Strong analytical, problem resolution, and project management skills. * Proficient in monitoring and managing record retention timelines for all clinical and regulatory documents and assistance in the preparation and review of documents...

Tags for this Online Resume: Data Entry, Database, Distribution, Filing, Documentation, Licensing, Medical, Microsoft Access, Regulatory Affairs, Research, clinical research

Featured Profile

Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality

Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...

Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.

Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA

Featured Profile

Experienced Safety Professional, MS OSHA, MESH, C-MESH,

Self motivated, team oriented, success driven individual; Seeking a challenging position within Occupational, Environmental Health and Safety field that will allow my extensive background to utilized and further developed .

Ideal Companies: SAS, Rockwell Collins, Northrup Grumman, Boeing, Honda, XPO, UPS, FedEx, Grainger, Corning, GE, Duke Energy, Progress Energy, Apple, Google, Amazon,

Tags for this Online Resume: Environmental, Health, Safety, Compliance, Regulations, Manager, Specialist, Hazardous

Featured Profile

Director or Administrator

A job where I can make best use of professional skills and 6 years of experience as useful contribution in organizational development by planning and coordination organizational projects. Generating various organizational policies and performing daily operations. Communication with supplier in order to decide cost of goods. Providing clerical support and assistance to management. Providing strong leadership to project t...

Ideal Companies: Research, Education, Safety, pharmaceutical, health care , research

Tags for this Online Resume: EKG, Medication Administration, Recruiting, Surgery, Financial, Clarify, Curriculum Development, Planning, Strategic Planning, Cardiology

Clinical Research - 17 Years of Experience - Near 92804

Director of Clinical Site Development Offering +15-years' experience of executive level clinical research site and staff development. Highly motivated, solution-focused, and proven leader with in-depth knowledge of industry regulations that govern clinical research. Solid track record of successfully developing elite industry preferred clinical research organizations from conception. Inspirational and innovative leader with...

Tags for this Online Resume: Audit, Leadership, Clinical Research, Research, ISO, Training, Compliance, Management, Procurement, Quality