PHARMA WISDOM

Greeting from Hetero Biopharma

We have an opening CQA

Company Name: Hetero Biopharma Ltd

Department: CQA

Designation: Asst Manager

Experience: 7 to 10 Yrs.

Job Location: Jadcherla (Telangana)

• Responsible for preparation and review of Corporate Policies and Core Quality System procedures to ensure harmonization across the Biopharma site/s.
• Responsible to ensure the Corporate Quality Operations for Biopharma facilities
• Updating the site/s with cGMP and current regulations from applicable regulatory guidelines and ensure compliance
• Measuring the site/s Quality Metrics and Key Performance Indicators (KPI) and report preparation.
• Ensuring the data integrity compliance at site/s
• Organizing in support the Annual Quality Review and Management Review meeting/s
• Responsible for Planning and Execution of Site Inspection Management & Logistics
• Responsible for ensuring the effectiveness of Self inspection programme at site/s
• Responsible for preparation and review of the Site Risk Management program
• Responsible to support external audits in the site and to prepare audit reports and provide CAPA to meet the compliance level.
• Responsible for training on the corporate policies / procedures of site key personnel
• Supporting the plant QA team in various quality projects like E-Systems and CSVs.
• To support and ensure in regulatory dossier compliance
• Responsible for monitoring the Quality systems and lab compliance of CGMP facilities
• Assure QbD (Quality by Design) principles to ensure robustness of Process and Product
• To ensure day-to-day activities in the cGMP area for the effective implementation of the corporate quality policies.

Any other responsibilities assigned by Head of the Department.