AstraZeneca Job Vacancy For Quality Control Department

AstraZeneca Job Vacancy For Quality Control Department

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.

Click here for apply