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Online Resumes with "Batch Production Record"
Technical Supervisor
Hi, I have been working for more than 10 years in the cancer research field. I have worked in 3 different biotech companies to make autologous vaccines. I have been pretty consistent on working on making vaccines. I am looking for more responsibility and help the company with my knowledge in clean room environment techniques (GMP) and procedures (SOP). I am independent, autonomous worker, I am reliable and always volun...
Ideal Companies: Biotech like Novartis or MedFusion etc
Tags for this Online Resume: Cell culture, Aperesis consultant, Manufaturing associate, Flow Cytometry, RNA/DNA extraction, PCR/QPCR, Isolators, Autologous Vaccines
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
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
Quality Assurance Director
Ideal Companies: Large Pharma Companies
Tags for this Online Resume: Documentation, Diagnostics, Utilities, Audit, Complaints, Manufacturing, Product Development, Risk Assessment, Sales, ISO
Machine Operator - 7 Years of Experience - Near 94605
and Qualifications: GMP manufacturing technician experience, inclusive of filling and inspection operations. Trained and utilized MES, SAP, DocLink EDMS (Change Control), Trackwise and Electronic Equipment Use Log system. Performed batch production record review per GDP (Good Documentation Practice) standards. Performed batch production record revisions in filling. Performed fill line clearances in clinical filling operati...
Tags for this Online Resume: Manufacturing, SAP, Valves, Payroll, 5S, Merchandising, Inventory, Training, Change Control, Clean Room
