Aurigene Oncology Hiring for Quality Assurance – Sr. Executive

Aurigene Oncology, a leader in innovative cancer treatment solutions, is seeking a Sr. Executive for Quality Assurance at their Bangalore facility. This is a unique opportunity to join a company dedicated to advancing oncology treatments and making a difference in patients’ lives.

Job Overview

Position: Sr. Executive – Quality Assurance
Location: Bangalore, India
Experience: 5 to 10 Years
Qualification: MSc, M Tech, M Pharmacy in relevant fields

Key Responsibilities

As a Sr. Executive in Quality Assurance at Aurigene Oncology, you will play a critical role in ensuring that the company’s products meet the highest quality standards. Your responsibilities will include:

• AHU Qualification & Validation: Lead the qualification and validation processes for Air Handling Units (AHU), clean rooms, HVAC systems, and equipment, ensuring all protocols are executed according to GMP standards.
• Protocol Development: Develop and execute protocols for Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of various systems and equipment.
• Document Review: Oversee the review and approval of batch manufacturing records and validate technology transfer documents to ensure they meet all regulatory requirements.
• IPQA Oversight: Manage In-Process Quality Assurance (IPQA) for dispensing line clearance, manufacturing, packaging, and dispatch processes, ensuring all activities adhere to GMP guidelines.
• Change Management: Oversee change control processes and manage deviations, ensuring that all changes are documented and implemented correctly.
• CAPA Implementation: Investigate Out of Specification (OOS) and Out of Trend (OOT) events and implement Corrective and Preventive Actions (CAPAs) to address any issues.
• Compliance Monitoring: Maintain and update GMP validation procedures, ensuring continuous compliance through regular monitoring and audits.

Analytical Quality Assurance

• Document Review: Review analytical documents related to early-stage development, technology transfer, and pilot production to ensure accuracy and compliance.
• Collaboration: Work closely with QC scientists to ensure the quality of analytical documentation and support regulatory submissions by reviewing development documents.
• Laboratory Incident Management: Investigate and resolve laboratory incidents, including OOS and OOT events, to maintain high standards of quality control.
• Data Review: Review data related to specifications and test methods, ensuring all information meets the necessary standards and is accurately documented.
• Document Management: Maintain and track departmental documents and reports, ensuring they are up-to-date and accessible for audits and regulatory inspections.

Application Process

If you meet the qualifications and are ready to take on this challenging and rewarding role, Aurigene Oncology invites you to apply. Please send your updated resume to apoorva_s@aurigene.com.