| Senior Analytical or validation position - · Expertise in handling HPLC, GC, FT-IR, Auto analyzer, Dissolution, TGA, Column chromatography, UV-Vis Spectrophotometry, GPC, IC, Flame Photometry, Diode Array Spectrophotometry, TOC, HP Chemstation with LC1100, GC6890. Waters millennium32 4.0 with alliance HPLC with PDA and other detectors, HP1100 and HP6890 GC. Specialize in lab validation such as instrument validation such as IQ/OQ/PQ. Waters HPLC software validation for millennium32 version 3.2, 4.0 and Empower according to 21CFR part 11 compliances. IQ/OQ/PQ of Agilent HPLC HP1100 with ChemStation software. IQ/OQ/PQ of HP1100 with millennium32 version 4.0 software. Good hand on Perkin Elmer and Thermo Nicolet FT-IR. Design validation protocol for IQ/OQ/PQ of HPLC, GC and FT-IR. Design multiple HPLC connection using waters millennium software with the help of waters technical support and service engineer. Configure the Agilent HPLC HP1100 and Agilent GC 6890. Design the validation protocol for waters HPLC with Empower and Millennium software. Design validation protocol for stability software. Configure and assign password protection for 21CFR11 compliances for administration, chemist, analyst and guest. Expertise of validation and qualification of older models of stand alone HPLC and their components. Expertise in trouble shooting of HPLC, GC and FT-IR. Develop training protocol for laboratory personnel. Design backup and archived sop for HPLC data as per 21CFR11. Upgrade HPLC computer system for backup data from hardware as well as database. Design backup schedule for data, project and maintain their logbooks. Write SOP for backup, archived and restoring data from hard drive and database. I have expertise in IQ/OQ/PQ of PE Lambda 25 with UV-Win lab software and their IQ/OQ/PQ as per 21CFR part 11 compliances. · Expertise in MS window/office/Access/Internet/HTML/LIMS. Expertise in widely used business software application like MS money/Excel/Word/power point etc. Expertise on waters, HP and Varian Chromatography system and its application. Hands on stability software ScienTEK t6.5 Data Management· Executed data management and interactive programs to create computer data files for analytical results. Reproduce and interpreted graphs for transformed data. Preparing stability data using stability software. Preparing backup, archived data files and restoring them for reprocessing as per FDA and 21 CFR part 11 guideline and cGMP.. USA |
| Type: |
Permanent |
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| Location: |
USA |
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| Availability: |
ASAP |
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| Salary/Rate: |
65K/yr |
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| Reference: |
843 |
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