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Online Resumes with "SOP drafting"
Director
QUALIFICATIONS: Over twenty years drug development experience ranging from pre-clinical pharmacology / toxicology to managing and directing clinical and cross functional teams in the conduct and execution of global, clinical trials. Experience includes coordinating and planning for budgeting, resourcing, drug supply, site and sponsor audits, and global regulatory submissions. Management experience includes management of in-...
Tags for this Online Resume: Data Management, Management, Nephrology, Clinical Research, Clinical Study Reports, Drafting, Oncology, Project Management, Project Manager, Protocol
Life Scientist - 8 Years of Experience - Near 27617
Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
