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Senior Executive/ Executive for Method Validation

3.00 to 7.00 Years   Pune   02 Mar, 2024
Enzene Biosciences Ltd
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaNot Mentioned
EmploymentTypeFull-time

Job Description

    Accountabilities/Responsibilities:1. To perform analysis and review of analytical data for routine samples (In-process samples, Drug substances, Drug product release and stability samples), method transfer and method validation.2. Preparation and review of Documents (Specification, STPs, TDS, SOP, COA, MVP, MVR MTR etc.)3. Coordination with vendor for external calibration and with QC personal for in-house calibration and verification of laboratory instruments and equipment.4. QC materials (Chemicals, standards, kits and consumables) indent.5. Maintenance and management of laboratory equipment and instruments.6. Analyst qualification and QC employees training7. Initiation, investigation and tracking of QMS activities8. Ensure QC lab compliance in accordance with cGMPEducational qualification: M.SC., M. Pharm or Master degree in Biotech or relevant subjectsExperience: 3-7 years of experience in tasks such CEX-HPLC, SE-HPLC, ELISA and Capillary. Electrophoresis analysis.Soft skill competencies:Well versed with computer skill MS word, PPT etc,

Keyskills :
ELISAMS wordCEXHPLCSEHPLCCapillary Electrophoresis analysis

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