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Quality Manager - 20 Years of Experience - Near 00727

Manufacturing & Production Resumes - Quality Manager Resumes - Caguas, PR

OBJECTIVE: To work in an organization where I can generate dynamic results through my experience, to contribute to the development and success of the organization. PROFILE:Self-motivated problem solver with proven leadership and collaborative abilities. Enthusiastic and able to achieve rapport with prospects easily. Competencies: result oriented and goals achiever; excellent communication skills; professionalism, diplomac...

Tags for this Online Resume: Puerto Rico, Quality, GMPX, FDA, REGULATIONS, PHARMACEUTICAL

Process Engineer - 19 Years of Experience - Near 41105

Engineering & Architecture Resumes - Process Engineer Resumes - Ashland, KY

Hi, Referring to your advt post on ISPE for the position Director, Process Engineering, I am Shailesh; completed Masters in Process Design from one of Premier Inst. in India (Indian Inst. of Technology- Delhi) . Currently working with Biopharmax Ltd , since Sept 2015 as a General Manager (Design) handled- projects and Engineering Services in capacity of from 5Mn. to 55 Mn. USD.(Process & Infra. Projects) mostly for Joi...

Tags for this Online Resume: Pharma, API, and Biotechnology , Project Management, facility design, detailing, Pharma formulation and API unit Machinery, system, , USFDA, ANVISA, MHRA , Techno-commercial negotiations for terms sheets, contracts , Process scale-up, Bioreactor design, Project Management tools-MSP

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Quality Manager - 16 Years of Experience - Near 98012

Manufacturing & Production Resumes - Quality Manager Resumes - Bothell, WA

ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...

Tags for this Online Resume: Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk

Pharmaceutical Quality Assurance Specialist- 10 years Experince- Atlanta

Science & Biotech Resumes - Clinical Quality Assurance Resumes - Atlanta, GA

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

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Global Regulatory Affairs - 14 Years of Experience- New Delhi India 110021

Science & Biotech Resumes - Clinical Regulatory Affairs Resumes - Floral Park, NY

Seeking assignments as a Global Regulatory Affairs Professional - NCEs, GENERICS- Pharma, Biotech products, Botanicals & Medical Devices in Global Regions and/or Quality & Compliance professional across the Pharma & Medical Devices Industry. Overall Profile * With overall 15+ years industrial experience, with 14+ years in the field of Global Regulatory Affairs, Compilation & Submissions of Technical Packages for IND/CTA, ND...

Ideal Companies: BBraun Medical Pvt Ltd, New Delhi, India, Glenmark Pharmaceuticals Ltd., Mumbai, India, Panacea Biotec Ltd., New Delhi, India

Tags for this Online Resume: Regulatory Affairs, Management, Medical Devices, Pharmaceutical Industry, IND/CTA, Formulations & APIs, Regulatory Audits & Compliances, NCEs/NMEs/Generics, CT, Regulatory Consultancy, Regulatory Due Diligence & Gap Assessment

Microbiologist - 6 Years of Experience

Science & Biotech Resumes - Microbiologist Resumes - ,

Qualifications of equipment's. * Analyst qualifications. * On the Job training. * Testing method validation. MAJOR AUDITS FACED: USFDA, TGA, MHRA, ANVISA (Brazil), UKRAINE, GSK, NHL, W.H.O, DRUG CONTROLLER AUDIT. VALIDATION EXPOSURE: * Media fill validation * Antibiotic bio assay * Excel sheet validation for calculations. * Sterility method validation * Bioburden method validation * Microbial Enumeration Test * Bacterial En...

Tags for this Online Resume: Microbiology, Quality, Quality Assurance, Quality Control, Distribution, Test, Training, Audit, Communication Skills, English Language

Quality Manager - 14 Years of Experience - Near 00969

Manufacturing & Production Resumes - Quality Manager Resumes - Guaynabo, PR

Summary of Qualification Electrical Engineer with broad experience in the Electronic, Electro Mechanic and Pharmaceutical Industries. Green Belt and ASQ-CQE Certified, Black Belt Trained. Strong knowledge on CFR, Aseptic Pharmaceutical Manufacturing Process and cGMP. Managed major document types as Annual Product Quality reports (APQRs), Master Batch Records (MBRs), Standard Operational Procedure (SOPs), Stability Studies a...

Tags for this Online Resume: Quality and Compliance, Audit, Budgeting, GMP, REgulatory, Data Management, Documentation, Fabrication, KPI metrics, Leadership, Management, Change Control

Quality Manager - 17 Years of Experience - Near 60051

Manufacturing & Production Resumes - Quality Manager Resumes - Mchenry, IL

SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&...

Tags for this Online Resume: Software, 5S, Complaints, Documentation, ISO, Product Development, Systems Analysis, Black belt, Kaizen, Management

Quality Professional

Manufacturing & Production Resumes - Quality Engineer Resumes - Pacoima, CA

Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan inc...

Tags for this Online Resume: Manufacturing, Medical, Medical Devices, Risk Analysis, Documentation, Failure Analysis, ISO, Quality Assurance, Quality, Statistical Analysis

Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry

Science & Biotech Resumes - Clinical Regulatory Affairs Resumes - Palm Beach Gardens, FL

PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...

Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device