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Officer -Quality Assurance (Biotech)

0.00 to 4.00 Years   Pune   23 Oct, 2023
LUPIN
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Officer -Quality Assurance (Biotech)JD -1) Preparation & trending of stability study summary report annual results. Review of stability study protocol. Timely initiation stability study as per the SOP & ICH guideline.Monitoring of overall stability management program. Ensure that stability studies are being carried out b following a roved procedure/ protocols.2) The candidate may well verse with Quality Management Systems like: Change control, Deviation, CAPA, Market complaint, Investigation, OOS/OOT & NC management.3) Review of analytical and microbiological testing raw data for final batch release & stability study raw data. Candidate should have basic knowledge about different software / applications being used for Quality Management system.4) The candidate should have through understanding on QC analytical methods/ systems used for Biotherapeutics including but not limited to HPLC (SE-HPLC, HI-HPLC, RP-HPLC, IEX/ CEX-HPLC), Molecular biology (RT PCR), Electrophoresis (SDS-PAGE/ IEF/ Western Blotting), ELISA based assays (Host cell protein contaminants) and general procedures including but not limited to extractable volume, pH, conductivity, Particulate matter testing5) IPQA round to ensure that laboratory is ready to face audit as per current regulatory requirements.,

Keyskills :
batch releasechange controlmolecular biologystability studiesquality managementmanagement systemsichsophplcipqacapacellbasicelisatestingbiologycontrolsoftware

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