Associate - Quality Control

Job Description

Associate- Quality Control, based out at Yelahanka- Bangalore

Do you have expertise in, and passion for Quality Control? Would you like to apply your expertise in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

BUSINESS AREA

Quality Control

Commit to making a difference beyond patients, pioneering AstraZeneca’s sustainability strategy. Have the opportunity to be a key contributor to Zero Carbon by 2025 and carbon negative across the entire value chain by 2030. Everyone can contribute towards our collective legacy of doing good for people, the environment and society.

What you’ll do

Conducts Quality Control Chemical testing on products/material to ensure compliance with specification. Has sign-off authority. Conducts trouble-shooting of laboratory equipment.

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.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
• If you’re curious to know more then please apply to this post and we will revert back to you.

Where can I find out more?

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