Executive / Senior Executive - QA (Biologics)

Required Qualification & Experience:

• M.Sc. in any Life science(s)/Analytical/M-Pharmacy, with 3 - 6 Years of experience in the field of pharmaceutical industry/CRO setup.
• on Multimode microplate reader (MMMR) related studies involving Bioassay, Biochemical/cell-free assays, Iron Complex Drug Studies, Bioanalytical studies (IVBE), Thio-T binding studies for Fibril estimation, Protein and DNA quantification studies of various molecules or peptides
• Knowledge on CDSM (Circular Dichroism Spectrophotometer) for Secondary structure estimation of various molecules or peptides
• Audit trail review of various instruments such as LCMS, HPLC with Empower, Lab Solution and Mass hunter software
• strong understanding of Data integrity principles.

Job Responsibilities

• Review of Cell-based assays, Biochemical/Cell-free assays and Bioanalytical (method development, method validation and batch analysis) related protocols, raw data and reports including Audit trails in respective software
• Review of Method development, validation, batch analysis, SOPs and other relevant data
• Equipment Qualification and calibrations data review
• Review of data in Various softwares such as PLA, Softmax pro, Jasco- Spectra max.
• Assists the group leader in instrument qualifications, implementing laboratory procedures and systems
• Audit trail review of various instruments such as LCMS, HPLC with Empower, Lab Solution and Mass hunter software .
• Performs in-charge duties for the allocated lab/equipment/inventory/supporting activities and takes responsibility for the timely completion of the tasks assigned.
• Demonstrates a strong desire to continue learning and grow personal capability.

Interested candidates share across your updated resume to hr@chiral.daicel.com with subject line: QA-Biologics