Tiefenbacher Laboratories is a leading global pharmaceutical research and development organization, committed to delivering high-quality, affordable medicines to improve global health. Part of the Tiefenbacher Group, the company specializes in the development of generic and innovative pharmaceutical products across multiple therapeutic areas. With cutting-edge R&D capabilities, a strong focus on quality assurance, and a mission-driven approach to healthcare innovation, Tiefenbacher Laboratories partners with major pharmaceutical companies worldwide to bring safe and effective treatments to market.
Requirement Details :
DEPARTMENT
• Quality Assurance (DQA)
DESIGNATION
Asst.Manager, Dy.Manager, Manager levels
EXPERIENCE
• 08 to 14 years
QUALIFICATION
M.Pharmacy / B.Pharmacy
JOB SKILL:
• Responsible for review and approval of Process development documents like Master Product Card, Reference Formula Card, Study medication batch records, Product development reports & Batch selection reports.
• Responsible for impact assessment & coordination of Change controls and Deviations of Analytical and Product Development Laboratories.
•Responsible for review of audit trials in Analytical Development Laboratory.
• Responsible for review of documents and support for submission of dossiers/ CTD.
& Responsible for compilation of Technical Data Package, Nitrosamine Risk Assessment and ICH Q3D elemental impurities risk assessments.
• Responsible for review of OOS/ OOT and Incidents annual summary reports.
•Responsible for review of SOP’s and Formats related to Quality Assurance, R8D activities.
• Responsible for review of Process development documents like Master Product Card, Reference Formula Card, Study medication batch records, Product development reports & Batch selection reports.
How to apply ?
k.surendra@tiefenbacher.com
www.tiefenbacher-pharmaceuticals.com
