Associate – Quality Assurance
Location: India - Yelahanka
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
This role Supports QA Manager to establish and sustain the culture of regulatory compliance at India site and contributes to the QA function in executing and developing a quality management system and supports the sites improvement. Knowledge towards the Schedule M requirement and AZ QCM standards is essential.
Key Duties and Accountabilities
- Ensure that cGMP’s requirements are adhered as per the Schedule M and AstraZeneca QCM.
- Documentation control this includes maintenance of archival System by RMA tool.
- Issuance, control and maintenance of Standard Operating Procedure, Work instruction and Formats through Azdoc System.
- KPI trending compilation and updation to Global Portal.
- Support the preparation and execution of internal and external audit and inspection.
- Support in implementation of improvement plan identified through investigation.
- Awareness on lean culture, drive improvements and process simplification and lead or participate on interdepartmental Projects as required.
- Knowledge in SAP on Quality Module.
- Support the management of Quality management System
- Knowledge in Risk management system and deviation investigation.
- Reference sample management.
Essential for the role
- Master’s in science / Pharmacy Graduate 3 to 6 Year experience in Pharmaceutical Quality Assurance.
- Conversant with Good Manufacturing Practice (cGMP) & QMS
- Fluency in computer systems including Microsoft applications, Essential SAP Knowledge.
Desirable for the role
- Communication Skill.
- Knowledge in Tablet manufacturing Process & Shopfloor QA
- Basic of SHE and Lean
- Knowledge in QC testing and review.