Chemistry Associate Quality Control Job Vacancy @ AstraZeneca

Chemistry Associate Quality Control Job Vacancy @ AstraZeneca

Chemistry candidates are encouraged to apply online at AstraZeneca for an Associate Quality Control. Interested and eligible candidates with a chemistry background and relevant experience, please check out all of the details on the job that is available. Check out all the details on the same below:

Job Title: Associate Quality Control

Eligibility: Master’s degree in Chemistry or equivalent

Experience:

  • Experience in a Good Manufacturing Practice environment
  • Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice.
  • Working experience: Minimum 3 years’ experience in the analysis of Pharmaceutical quality control with GxP environment

Desirable

  • Hands on experience in QC Instrumentations including troubleshooting.
  • Through knowledge of cGMP.
  • Management of Stability Studies.
  • Able to manage the team in a small group/ Good Leadership skill.
  • Sound knowledge on Reviewing of Documents.

Professional Knowledge and Skills

  • Thorough understanding of GMP
  • Hands on experience in QC Instrumentation and Chemical Analysis
  • Good communication skills
  • Computer Skills

Job Responsibilities

Sampling of Raw Materials & Sample Management

  • Make sure that the Samples are entered in the Receipt register or received electronically in GQCLIMS.
  • Storage of Samples.
  • Inspection of Container(s).
  • Sampling of Raw Material (s) (Adherence to SOP).
  • Reporting of Deviations (if any) to the line manager.
  • Reference Sample and Residual sample management.

Analysis

  • Routine and non-routine testing including cleaning validation, complaint / counterfeit analysis, experimental / validation work, analytical support to production and timely reporting of Deviations/ OOS/OOT.
  • Ensuring progressive entry during analysis.
  • Printing & affixing of approved and rejected labels.
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Document Preparation Review & Archival of Document

  • Preparation and Review of Documents (Example: Protocols / SOP’s Specifications/ Methods/ Risk Assessment Documents).
  • Authorised to perform Level 1 and Level 2 Sign off.
  • Review of reports and ensuring GMP compliance.
  • Archival of Current Documents / Reports.

Disposal

  • Segregation waste.
  • Identification of expired reagents/ Solutions/ Chemicals/ Mobile phase etc.
  • Ensuring the disposal as per the SOP.

Training and Coaching

  • Provides analytical expert knowledge and support to the Quality Control Function – troubleshooting issues and delivering training and coaching.

Calibrations  / Qualification/ Preventive Maintenance (Internal & External)

  • Preparation of Calibration/ Preventive Maintenance Schedule.
  • Monitoring / Execution and reporting.
  • Co-ordination with external vendor.
  • Qualification of Instruments (IQ/OQ/PQ/DQ).

Investigation

  • Reporting of OOS /OOT/Deviations in Timely manner .
  • Performing investigations.
  • Identifying root cause for failure and CAPA.
  • Inventory Management.
  • Identification/ Procurement/ Storage and labelling.
  • Management of Reference Standards/ Working Standards /Reagents/ Solutions / Miscellaneous Items.

External/Internal GMP Inspection

  • Ensure GMP Compliance all the time.
  • Regulatory Support.

SHE responsibility

  • Identify and understand the SHE risk factors within the department.
  • Develop and carry out plans to address the key SHE issues in the work place and follow up
  • Follow SHE standards all the time.

Quality Overview

  • Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit.
  • Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
  • Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through participation in management reviews and through advocating continual
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Last Date To Apply: 19-Jun-2019

Apply Online

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