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Online Resumes with "Investigation CAPA"
QA/QC Management Pharmaceutical Industry 19yrs experience Pennsylvania
I am a Quality Assurance Professional with over 19 years experience in the Pharmaceutical Industry. I am looking for a challenging role in Quality Assurance Management where I can uses my knowledge of cGMP/GLP and my skills in Team Leadership, Process Excellence, Investigation/CAPA, and Validation.
Tags for this Online Resume: Analytical Laboratory Management, Process Excellence, People and Talent Development, Technical Writing and Non-Conformance Investigations, Marketed Product Stability, Method Validation and Transfer, Complaint Vigilance, Change Management
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
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Biologist - 20 Years of Experience - Near 33543
Tags for this Online Resume: Quality Systems, Pharmaceuticals/Biotechnoogy, Medical Devices, Cytology Lab Supervisor, QA Investigations and CAPA
Assistant Manager - 7 Years of Experience - Near 90032
Career Summary: Experience in the cosmetic industry. Responsible for maintaining programs for documentation, technical assurance of raw material, packaging, bulk product and finished product release specifications. Responsible in the assistance of investigations, CAPA and Non-Conformance Report Systems, Food Drug Administration company internal audits, conducts studies and experiments with materials, vendors, processes, sup...
Tags for this Online Resume: Complaints, Documentation, Good Manufacturing Practices, Manufacturing, MSDS, Packaging, Product Development, Product Launch, Project Management, Project Manager, Brands, Testing, Finished Goods, Bulk, Microbiology
Microbiologist - 20 Years of Experience - Near 80503
Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...
Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing
Quality Engineer - 20 Years of Experience - Near 92507
Personal Summary Extensive experience in Medical Device manufacturing (over 27 years) Worked with Pharmaceutical manufacturing industry (5+ years) Opened and reviewed complaints, performed investigative actions for submittal. Effectively work with cross-functional teams. Perform complaint investigations and reviews. Run root cause analysis, identification and implementation of CAPAs. Experienced with FDA auditors. Perform t...
Tags for this Online Resume: Quality Assurance, Documentation, Manufacturing, Pharmaceutical, Reviews, Compliance, ISO, ISO 9000, Packaging, ISO 9001, manufacturing, steel, production, quality
Not Listed - 14 Years of Experience
Professional Qualifications "Foro de Calidad Regulatoria" (2014) * Training of Structured Problem Solving and Investigation Report Writing Effective Check, Caguas, PR (2014) * Training to Certify Quality Auditor (ASQ), Guaynabo, PR (2013) * "Mejorando tus Auditorías Internas", Caguas, PR (2012) * Train the Trainer Certification, Caguas, PR (2012) * First Aid Certification, Caguas, PR 2012 - 2016 * CAPA Certification, Caguas...
Tags for this Online Resume: Chemistry, Hazardous Waste, Instrumentation, Millenium (Sw-Fin/Admin), Millennium, pH Meter, Quality, Quality Assurance, Quality Control, SAP
Quality Coordinator - 20 Years of Experience - Near 00705
Summary of Over 39 years of successful experience in Quality (Quality Assurance/Quality Qualification Control/Quality Operation) in the pharmaceutical and medical device manufacturing area. Strong knowledge of investigations and CAPA. Excellent knowledge in cGMPs, Incoming inspection, complaints handling, validations, change control, packing material, manufacturing and packaging area. Strong leadership, negotiation, communi...
Tags for this Online Resume: Filing, Management, Packaging, Audit, Injection Molding, Policies and Procedures, Quality, Quality Assurance, Quality Management, Medical, healthcare, Healthcare
Quality Control
SUMMARY OF QUALIFICATIONS Quality Systems - Quality Control /Quality Assurance Management of Analytical Laboratories/Quality Audits/Scientific Technical Services Liaison Highly motivated, key contributor in Quality Management and cGMP compliance with more than twenty five years of demonstrated growth and success in scientific applications with Contract Manufacturing Organizations in Quality, R&D and manufacturing. Recognize...
Tags for this Online Resume: Analytical Chemistry, Chemistry, Manufacturing, Research and Development, Commercial Production, Compliance, Packaging, Pharmaceutical, Documentation, Quality, validation, Audits
Microbiologist
A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation p...
Tags for this Online Resume: Manufacturing, Assessments, Automation, Utilities, Microbiology, Protocol, Collection, Documentation, High Performance Liquid Chromatography (HPLC), Marketing Management
Life Scientist - 15 Years of Experience - Near 19426
To secure a position as a Senior Quality System Consultant.
Tags for this Online Resume: Validation Specialist, Quality Specialist, SAP, Annual Product Review, Auditor, Investigation CAPA, TrackWise, Batch Release, Documentation, Product Development
