CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "USFDA"

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Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.

Tags for this Online Resume:  Develop, maintain and manage appropriate study documentation,  Developing, writing and presenting the clinical trial protocols,  Initiate, maintain and reconcile Trial Master File.,  Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise.,  Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data.,  Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines,  Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.,  Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

chemist-6 years experience,expert in HPLC,GC and GMP

I want to be a lab manager and grow in terms or knowledge and experience in pharma or biotech QC lab

Tags for this Online Resume: HPLC, GC, cGMP, USFDA, GLP, leading teams

Chemical engineer more than 12+ years experience in chemical industries both manual and automation industries(PLC,DCS, SCADA operation, ABB automation tool)

n Commissioning a Plant n Troubleshoot plant failures n Pipeline Design n Handling Hazardous Chemicals n Handling Equipments n Basic Equipment Repairs n Safety Standards n Quality Controls n Plant Maintenance n cGMP and SOP knowledge n Maintain BMR’s of USFDA n Blueprint Interpretation n Environmental Standards n Process Validation

PHARMA PRODUCTION

I have 20+ years of experience in Pharma API Bulk drug production department. I handle total production activity like production plan, Micro production plan , Raw Material Plan, manpower schedule, daily production report, Weekly production report and monthly production report, co ordination with QA,QC,Store,engineering department. Implementing process modifications for enhancing operational efficiency, productivity and opt...

DATA MANAGEMENT ANALYST - 4.5 YEARS EXPERIENCE - Bangalore India

To work learn and grow with an organization to reach a high level in Regulatory Submission Management hierarchy and be instrumental in driving it beyond its mission by adhering to its values and cultures and utilizing my potential and talent to its fullest.

Tags for this Online Resume: Regualatory Publishing, Regulatory Affairs, Submission Manager, Health Authority , ISI Tool Box, eCTDXpress, ISI Publisher, Liquent, Insight Publisher, CMC Documentation, USFDA, EMEA, MHRA

Clinical Research - 10 Years of Experience - Near 11801

Cover Letter Rupal brahmbhatt Respected sir/madam ,, My self Rupal Patel Brahmbhatt. I was working at Synchron Research Services a leading CRO of India. I have been the part of this organization from when it was established, and still I was working with the same organization from 12 years. I have been a part of more than 700 projects as well as clinical studies including USFDA submission projects. I have face the US...

Tags for this Online Resume: MS office, GCP, SOP, CRA, ICF, CRC

Process Engineer - 19 Years of Experience - Near 41105

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

Pharmaceutical Quality Assurance Specialist- 10 years Experince- Atlanta

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

Scientist - 15 Years of Experience - Near 30045

PROFESSIONAL SUMMARY * Result oriented, Creative, Passionate, highly focused, experienced Pharmaceutical R&D Scientific Lead with good ethics, possessing over 15 years of experience in Formulation design, Process Development, Optimization and Scale up of various Pharmaceutical Dosage Forms, Solid Orals (IR and ER Tablets and Capsules), Liquid Orals (Solutions, Syrups and IR / ER Oral suspensions), and Parenteral formulation...

Tags for this Online Resume: Product Development, Filing, Pharmaceuticals (Generics), Formulation Research, Management, Budgetary, Process development, Oral solid dosage forms, Manufacturing, ANDAs

Chemist - 4 Years of Experience - Near 77598

Professional Summary: -Develop testing protocols - Identify new and replacement raw materials as necessary - Develop method of testings - I have experience in lab testing: 1) Ph 2) water content 3) thin layer chromatography 4) Density 5) analytical balance 6) IC 7) GC 8) GC_MS 9) AA 10) UV/VIS 11) FTIR 12) Oxidation stability 13) Chemical titrate 14) Antek9000 15) Refractive Index - Participation in USFDA accreditation. - H...

Tags for this Online Resume: Management, Manufacturing, Material Management, Pharmaceutical, Associate Customer Service, ASTM, Balance, Chemistry, Macromedia Flash, Microsoft Excel

Microbiologist - 6 Years of Experience

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