SENIOR EXECUTIVE (3607)

  • Company:
    Syngene International Ltd
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    2 weeks ago
  • Category:
    Healthcare | Biotechnology/Pharmaceutical/Medicine

Skill: sap , reconciliation , verification , senior executive; Exp: 2-3 years; 1. Daily laboratory monitoring, responsible to perform, record and review the daily/monthly Verification, calibration of Equipment’s and Instruments. 2. Preparation of QMS documentation such as SOPs, IOPs, EOPs etc. 3. Preparation of batch release documents like Specifications, TMRs with observation data sheet, verification protocols, Method transfer protocols etc. 4. Responsible to perform the Method Transfer analysis and Verification activity with documentation for the samples of In-Process/Finished product. * Job Description Job Description Required. Primary Responsibilities 1. Daily laboratory monitoring, responsible to perform, record and review the daily/monthly Verification, calibration of Equipment's and Instruments. 2. Preparation of QMS documentation such as SOPs, IOPs, EOPs etc. 3. Preparation of batch release documents like Specifications, TMRs with observation data sheet, verification protocols, Method transfer protocols etc. 4. Responsible to perform the Method Transfer analysis and Verification activity with documentation for the samples of In-Process/Finished product. 5. Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples. 6. Execution of In-process, finished product and stability sample analysis, documentation (Writing Observation data sheet, Updating of Stability summary sheet and Trend sheets) and recording of results in Technical information sheet and SAP. 7. Responsible for the preparation of Stability study related documents like, Stability study Protocols, observation data sheet, analysis report, stability summary and trend sheets. Responsible for the execution of stability samples charging for stability study. Responsible to Initiate and inform immediately to department HOD/designee, if there is any Laboratory Incidents, deviations, Change controls and out of specification results were observed. Responsible to complete all planned Quality & Compliance training as and when required by the department/section or asked by the HOD/designee. Responsible to conduct any job assigned by the superior. This position is for shift operations Primary Responsibilities 1. Daily laboratory monitoring, responsible to perform, record and review the daily/monthly Verification, calibration of Equipment’s and Instruments. 2. Preparation of QMS documentation such as SOPs, IOPs, EOPs etc. 3. Preparation of batch release documents like Specifications, TMRs with observation data sheet, verification protocols, Method transfer protocols etc. 4. Responsible to perform the Method Transfer analysis and Verification activity with documentation for the samples of In-Process/Finished product. 5. Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples. 6. Execution of In-process, finished product and stability sample analysis, documentation (Writing Observation data sheet, Updating of Stability summary sheet and Trend sheets) and recording of results in Technical information sheet and SAP. 7. Responsible for the preparation of Stability study related documents like, Stability study Protocols, observation data sheet, analysis report, stability summary and trend sheets. Responsible for the execution of stability samples charging for stability study. Responsible to Initiate and inform immediately to department HOD/designee, if there is any Laboratory Incidents, deviations, Change controls and out of specification results were observed. Responsible to complete all planned Quality & Compliance training as and when required by the department/section or asked by the HOD/designee. Responsible to conduct any job assigned by the superior. This position is for shift operations

Audit & Risk

Degree: 

Experience: 2-3

Function: Accounting / Tax / Company Secretary / Audit