HYDERABAD · FULLTIME
Sr Executive / Assistant Manager - QA (IVD)
Promea Therapeutics
Hyderabad · onsite · Posted 3d ago
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Undisclosed3–6 yrsfulltimeHyderabad
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Section · 01
About this role
1. Responsible for implementation of cGMP in the plant.
2. Responsible for review of SOPs.
3. Responsible for preparation of Quality Documents such as SMF, Quality Policy etc.
4. Responsible for review and compilation of Deviations, Incidents, Change Control and Root Cause Analysis.
5. Responsible for review and proper implementation of CAPA.
6. Responsible for conducting and preparation of Self-inspection reports.
7. Responsible for handling of Market Complaints & Product Recall.
8. Responsible for providing trainings.
9. Responsible for approval of Certificate of Analysis, Specifications, STPs and SOPs.
10. Responsible for review of approved vendor list of Raw Material & Packing Material.
11. Responsible for review of Master Packing Card, Master Formula Card, Batch Manufacturing Records & Batch Packing Records.
12. Responsible for ensuring the Design and development processes meet regulatory and quality standards.
13. Responsible for risk management associated with IVD products.
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
QAmarket complaintsCGMPCompilationCAPAChange ControlRoot Cause AnalysisRaw MaterialBatch Manufacturinginspection reportsRisk ManagementManufacturingPacking Material
Section · Company
About Promea Therapeutics
Promea Therapeutics
Medical Equipment
501
employees
2017
9 years old
Hyderabad/Secunderabad, Telangana
India
About
Promea Therapeutics is an innovative medical device manufacturing company specializing in Life Science products, Diagnostics.
Industries
Medical EquipmentBiotechnologyPharma
Employee ratings
225 reviews
4.1/ 5
Culture
3.9
Career growth
3.7
Work-life
4.0
Employees rate it well for
Senior Management31Learning28Work Culture26Work Environment24Team Members14
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