AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
Post : Associate - Quality Control
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.
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 improvement.
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Candidate Profile
Essential
• Qualified to Post Graduate degree level/or equivalent in a scientific discipline
• Should be 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
• 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.
Professional Knowledge and Skills
• Thorough understanding of GMP
• Hands on experience in QC Instrumentation and Chemical Analysis
• Good communication skills
• Computer Skills
Additional Information
Experience : 3 year
Qualification : M.Sc, B.Sc
Location : Yelahanka Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Control
End Date : 20th June, 2019
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