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 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
- 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
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.
- 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.
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.
- 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).
- 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.
- 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.
- 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
Last Date To Apply: 19-Jun-2019
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