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.
Join for Regular Job Updates in What's App & Telegram
No comments:
Post a Comment