Biocon Hiring for MANUFACTURING QMS (Biocon Biologics) at   Bangalore Full Time

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan.

Manufacturing operations, ensure compliance (GMP & GXP)as per regulated market requirements

QUALITY MANAGEMENT SYSTEM(QMS)

ROLES AND RESPONSIBILITIES

· Overall QMS responsibility of manufacturing operations and facility management.

· Ensure compliance (GMP, GXP) with appropriate SOP’s as per regulated market requirements

· Ensure compliance with appropriate SOP’s, policies and guidelines for operations in manufacturing plant

· Monitor performance metrics, draw conclusions, and make recommendations in the manufacturing review meeting (MRM) forum

· Identifying compliance issues and product quality issues and championing solutions

· To Identify risks and escalate them to the department head and relevant functional heads.

· Identifying needs for performance improvement and interacting with users and training departments

· Responsible for identification of repeat and overdue QMS events and ensure proper CAPA is in place to stop such events

· To review all , Protocols and other closure reports and ensure they comply to regulatory audits.

Requirements:

· Graduate/Post graduate in life sciences with 10+ years of experience

· Knowledge in manufacturing process of large scale bioreactors of biologicals for commercial and clinical requirements

· Good communication and interpersonal skills

· Problem solving skills, highly motivated with a results driven approach