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...

Experienced pharmaceutical laboratory manager and analytical chemist with expertise in GLP and GMP compliance and solid dosage forms.Extensive experience in pharmaceutical, nutraceutical and chemical industry analytical laboratories.Laboratory management and analytical laboratory improvement, cGMP and GLP compliance and problem resolution.Pharmaceutical process, cleaning and analytical methods validation.Solid dosage for OTC drug products.Responsibility for QA/QC functions for testing, complaint handling, customer audits and data analysis for over 300 different drug products.Training on cGMP and GLP compliance and problem resolution.Docume...

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 Analytical Chemistry Consultant Specializing in Method Development, Method Validation, Cleaning Validation and Verification, Drug Stability and cGMP, FDA and ICH Quality and Compliance.Analytical method development and method validation for small molecule pharmaceuticals.Cleaning validations and cleaning verifications.OOS (Out of Specification) and OOT (Out of Trend) investigations.Stability management.Setting specifications for finished products and API.Project management for CROs (Contract Research Organizations).Formulation development support.Pharmaceutical quality control.Protocol and SOP (Standard Operating Procedures...