Dear All,
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.
Interested Candidates can share your profile to edukondalu.m@heterodrugs.com
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