Pharmaceutical Quality Systems Implementation, Training and Audit ConsultantForty years of pharmaceutical and biotech industry experience - Production and development environments.Validation (computerized systems, equipment, processes), pre-acquisition - due diligence, quality assurance, compliance, quality control, research and development, technology transfer and clinical operations.Small and large molecule and vaccines, (Flu, Anthrax, and Rabies).International and domestic experience and assignments, (Europe, China and India).Exit strategy development, tracking and adjustment.Working with small, medium and large firms, assisting and man...

Seasoned pharmacists with years of experience in drug development, drug delivery, controlled release and statistical quality assurance of production.Expert in managing drug product development of new chemical entities, novel drug delivery systems (film coated tablets, chewable tablets, rapidly disintegrating tablets, effervescent tablets, controlled release tablets, liquids, suspensions, parenterals, etc.). Highly experienced in formulation development, quality assurance, PAIs, and authoring NDA/CMC documents.Thoroughly familiar with GMP, GLP, and FDA expectations.Pharmaceutical Product R&DDrug DeliveryStatistical Optimization of Pharmace...

Canadian regulatory affairs expert prepares pharmaceutical and medical device submissions and audits manufacturing quality practicesPharmaceutical Good Manufacturing Practices (GMP) for Canada.Regulatory Affairs Canada, submission preparation.Change control and complaint management.Pre-approval inspections.Pharmaceutical Quality Systems, clinical trial supplies.Qualification and validation: process, equipment, cleaning and test methods.Water for pharmaceutical purposes.Bioanalysis.Adverse event management; deviation and out-of-specification investigations.Sterile product manufacturing; environmental monitoring.FDA, QA, QC, quality assuran...

Pharmaceutical Compliance Consultant: FDA Regulations & Submission with Management Experience at Indian Pharmaceutical CompaniesPharmaceutical quality assurance and regulatory affairs.Skilled in Indian pharmaceutical research and development with leadership positions at Ranbaxy Laboratories, Strides Arcolab, Unilever and Ciba Geigy, all in India.Pharmaceutical GLC and GMC compliance audits, QA operations and regulatory submissions.Pharmaceutical quality control for analytical equipment, method development and validation.Synthesis of active pharmaceutical ingredients (API) and API isolation, identification, impurities and degradation produ...

Pharmaceutical Quality Auditor: Excipient GMP auditing, International IPEA, and ISO standards, 9001, 17025, 14065Certified Quality Auditor with 20 years experience of working with quality systems.Trained in a number of ISO standards, Pharmaceutical Excipient GMP auditing and is an approved auditor for International Pharmaceutical Excipients Auditing (IPEA).Experienced with ISO 9001, ISO 17025, ISO 14065 and Lexcel, Law Society's practice management standard.Undisclosed Company, Director, 2008 - PresentA consulting firm servici...

GMP, ISO Quality, Compliance, and Audit Expert for Pharmaceutical and Medical DevicesGMP and ISO matters relating to quality control and quality assurance in the medical device, dietary supplement and pharmaceutical industries.Good Manufacturing Practices (GMP), and ISO Certified Lead Auditor.Document control, training, supplier and quality assurance.Auditing, document control, training, supplier and contract quality assurance.Process validation and contractor managementQuality control and quality assurance for a facility producing tablets, aerosols, suppositories, time-release capsules, medical devices and small volume parenterals. Inject...

Pharmaceutical and Biotechnical Quality Assurance Consultant - Regulatory, GMP, GLP, ISO, ICH, FDA, Drug Development, Manufacturing and Aseptic Processing. PhD Consultant Specialized in New Product Research, Scale-Up, Compliance, Production Development, New Applications and CommercializationPharmaceutical and biotechnical quality assurance.Broad knowledge of GMP, GLP, ISO, ICH, FDA and International regulations.Managing multiple projects and complex priorities.Drug development, pharmaceutical manufacturing and aseptic processing principles and requirements.Focused AreasProduct releaseProduction batch recordChange controlCommissioning,...

Development and Implementation of Phase-Specific Quality Systems and Pharmaceutical Production and TestingPharmaceutical quality assurance management and corporate quality strategy planning.Development and implementation of phase-specific quality systemsIdentifying and correcting road blocks to efficiency and complianceGMP facility design, construction management, validation and licensing of GMP manufacturing facilities.Proven success in U.S. and E.U Inspections of manufacturing and laboratories.Over 20 years of valuable experience developing and managing highly productive work groups in small to mid-size pharmaceutical.

Pharmaceutical Manufacturing Production Consultant in QA/QC, GMP, Root Cause Analysis, Non-Conformance (NOE) InvestigationsPharmaceutical industry Good Manufacturing Practices, (GMP) and ISO Standards.Ability to manage multicultural environments, motivate staff members and implement company objectives.Diverse manufacturing and compliance activities.TPS tools, Lean, Six Sigma and Toyota Kata.Latin America experienced. Bilingual, Spanish and English.Undisclosed Company, Manufacturing - Quality, 2014 - 2015Director of O...

Pharmaceutical Operations - Small to Mid-Sized Companies, from Technology Transfer through Packaging and Distribution, and with Companies Under Regulatory or Financial DuressLife sciences manufacturing with specific focus to technology services, quality systems, engineering oversite, strategic and tactical planning strategies.Providing supply chain consulting and compliance achieving profitability goals, utilizing Lean Six Sigma.ServicesLean Six Sigma Black Belt.Pharmaceutical manufacturing.Pharmaceutical process engineering.Pharmaceutical continuous improvement.Quality engineering and quality systems.Quality Systems Implementation.Cont...