Greetings from Hetero Biopharma..!!!
We are hiring for CQA department
Designation: Asst. Manager
Experience: 7 to 10 years
Job Location: Jadcherla, Hyderabad
- 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.
Interested Candidates can share your profile to [email protected]