AstraZeneca Job Vacancy For Quality Control Department
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| AstraZeneca Job Vacancy For Quality Control Department |
Post: Associate- Quality Control, based out at Yelahanka- Bangalore
Key Duties and Accountabilities
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.
Water Testing
Make sure that the Samples are entered in the Receipt register or received electronically in GQCLIMS
Sampling
Testing
Trending
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.
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
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)
Monitoring / Execution and reporting.
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.
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 improvement.
Essential
Qualified to Post Graduate degree level/or equivalent in a scientific discipline
Experience in a Good Manufacturing Practice environment
Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory Practice
Working experience: Minimum 3 years’ experience in the analysis of Pharmaceutical quality control with GxP environment
Computer and Language: Good computer and English communication skill.
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.
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