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Online Resumes with "Consent Decree"
General
SUMMARY Pharmaceutical Professional 20 years' experience, Quality Assurance, auditor batch review /release, Clinical Supplies, OTC and Governance meeting manager, worked in a Consent Decree environment with special projects, audit, and review and approve label change controls folders, Bill of Materials setup, master batch records, validation documentations. label inspection/review, quality notifications, produce/update sour...
Tags for this Online Resume: Manufacturing, Proofreading, Management, Packaging, Project Management, Audit, Distribution, Documentation, Inventory, Process Improvement
Quality Coordinator - 5 Years of Experience - Near 08817
PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...
Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting
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
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology
Environmental / Compliance Management Systems - 20 Years of Experience - Near 77077
Objective: A senior management position in which I will contribute to business value by developing and executing a strategic, long term vision in the area of environmental, health and safety. This ideal position will leverage existing leadership and influencing skills and provide the opportunity to play a direct role development of team members and stakeholders. Overview: Twenty-year Petrochemical and Oil & Gas Indust...
Ideal Companies: Oil and Gas Industry, Chemical Industry
Tags for this Online Resume: Environmental, Compliance, Regulatory, Management, Air, Waste, Water, Team Leader, Assessments, Audit
Manufacturing and Operations Leader
Highly adept business leader with a strong track record of successful change management in manufacturing and engineering based organizations. Demonstrated ability to excel in management roles with progressive responsibility. Robust background in all areas of Operations management with over 20 years of experience focused on NPI, Lean deployment, site transfers, cost reductions, and QMS compliance. Energetic, people-oriented...
Ideal Companies: Medical Device manufactures
Tags for this Online Resume: Change Management, Coaching, Engineering, Kaizen, Leadership, Management, Manufacturing, Manufacturing Engineering, Medical Devices, Inventory Management, Business Process Improvement, Lean, Continuous Improvement, Quality System, Supply Chain, Warehousing, Process Management, Budget Management, Organizational Develpment, Servant Leadership, Cost Savings, Capital Acquisitions, Plant Leader
