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Online Resumes with "Validations Protocols Reports "
Dr. JI-CV
Principal or Sr. Scientist in Pharmaceutical Analytical R&D, or drug development
Ideal Companies: Pharmaceutical Company or Drug development and research
Diligent and results-oriented Chemical Engineer with extensive experience in chemical, environmental, and health and safety engineering, as well as background as manufacturing supervisor and compliance and validation specialist. • Excels in leadership p
Tags for this Online Resume:
Chemical Engineer, Product Transfer, Technical Services, Validations (Protocols, Reports), General documentation (CR), Investigations (CAPA)
QA ASSOCIATE - 3 Years of Experience - 08873
• Ensure implementation of cGMP, GLP and GDP
• Monitoring processing and laboratory activities in the facility on a daily basis
• Hosting regulatory audits
• Member of internal audit team
• Preparation and implementation of Standard Operating Procedures, Stability Protocols, Master Batch Production Records, etc.
• Evaluation and Qualification of vendors for raw materials, packaging materials and contract services
• Samplin...
Tags for this Online Resume:
QUALITY ASSURANCE, QA TECNICIAN, VALIDATION, DOCUMENTATION, QA AUDITOR, BMR, Test, Audit, Documentation, Internal audit, Manufacturing, Microsoft, Microsoft Office, Packaging
Production Manager - 20 Years of Experience - Near 32825
PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...
Tags for this Online Resume:
Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management
Program Manager - 0 Years of Experience
Career Summary * Over a decade of experience as a Project Manager, primarily in the medical device industry, and inclusive of the following professional skills: * Project Management and New Product Development * Product Design & Engineering (for manufacturability, DFM) and Engineering Change Control * GMP, Good Manufacturing Practice, and Lean Six Sigma Manufacturing * Process Development and Statistical Process Control * I...
Tags for this Online Resume:
Training, Billing, Change Control, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, manager, civil engineering, architecture, construction management
Packaging Engineer/Manager-20+ Years Experience
QUALIFICATIONS Package development professional with notable success in development and launch of new initiatives and substantial cost saving efforts excellent written and oral communication skills ability to work effectively across different functions, and with diverse groups. Skills/experience include: * Develop packages to achieve the intended design, quality, cost objectives, functionality, and manufacturability. This n...
Tags for this Online Resume:
Packaging, Manufacturing, Business Development, New Business Development, Packer, Project Management, Project Manager, Retail, SAP MM module, Tooling
Quality Manager - 20 Years of Experience - Near 00727
evaluates Reviews and approves change control validation protocols and reports to all manufacturing processes as blending granulation compressing coating and printing. Maintains documents in an organized and traceable manner. * Provides advice and service to all operating departments as to assure compliance with cGMP's and other regulations. This includes frequent feed back on performance regarding deviations rejections com...
Tags for this Online Resume:
Manufacturing, Management, Complaints, Documentation, Pharmaceutical, Quality, Quality Assurance, Test, Packaging, Project Management
Chemist
SUMMARY OF QUALIFICATION An accomplished research professional with excellent communication skills who is organized, detail oriented and a team player. Has over 21 years of experience and extensive background that includes leadership role in analytical research in many reputed pharmaceutical organizations. KEY AREA OF EXPERTISE Lead and supervised a team of scientists to execute analytical method development, method validat...
Tags for this Online Resume:
DSC, Emerging Markets, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Management, Engineering, Reverse Engineering, Accounting, CFR Part 11, Cost Accounting
Featured Profile
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
Featured Profile
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
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
