Biological E. Limited invites Dynamic & Self-motivates candidates experienced, dynamic and self-motivated candidates for "Quality Control" injectable formulations department at its Pharma Business USFDA Approved plant, Shamirpet, Hyderabad:
Roles and Responsibilities
1. QC - Analyst role:
Position: Executive
Qualification: M.Sc./ M.Pharmacy
Experience: 2 to 5 years
Required Skills:
Raw Material (API & Excipients) Analysis by HPLC, IC for Assay, RS, Isomeric impurity.
Finished Product Analysis (PFS, Lyo and Liquid) by HPLC, IC for Assay, RS, Isomeric impurity.
Bio Assay for Antifactor Xa and IIa Activity for Heparin and Low Molecular weight Heparin Injectable products.
Experience in auto titration and manual titration, Nitrogen analysis of Kjeldal method.
Analysis of Water content (by KF and coulometer), LOD, SOR, IR, UV spectrophotometer, MP, etc
Experience of handling advance instruments like NMR, ICP-MS, AAS, etc
Experience of Handling OOS & OOT
Knowledge of Empower software & LIMS, GLP, GDP is must.
Exposure to regulatory audits
2. QC - Reviewer role:
Position: Senior Executive
Qualification: M.Sc./ M.Pharmacy
Experience: 7 to 8 years
Required Skills:
Thorough technical knowledge in performing qualitative, quantitative and peptide analysis using instruments Like HPLC, GC, IC, Malvern, UV, IR, Autotitrator, XRD, ICP-OES etc.
Good experience in handling analytical softwares like Empower, IR solution, ES spectrum, Qtegra, Open Lab, chemstation, chromeleon, Diffrac eva, TIMO, LIMS, Metric stream(QMS), Nichelon, LIMS etc.
Experience in preparation and reviewing of specifications, STPs, SOPs, protocol, analytical documents, audit trials, Calibration reports and sample management in quality control laboratory.
Good knowledge on literature search using reaxys, scifinder, and patent search from patent data bases etc.
Exposure to regulatory audits
3. QC - GLP role:
Position: Executive
Qualification: M.Sc./ M.Pharmacy
Experience: 4 to 5 years
Required Skills:
Must have experience in GLP section.
Calibration of laboratory instruments like HPLC, GC, UV, AAS, ICP-MS, etc Handling of Reference standard/ Working standard management, Chemical, reagents, solvents.
Experience of Handling OOS & OOT
Knowledge of Empower software & LIMS is must
0 Comments