Associate- Drug Substance Downstream

Biocon; Johor Bahru; On-site; MYR 45,000 - 67,000; Full time

Job summary

Biocon Biologics, a global biopharmaceutical leader and subsidiary of Biocon Ltd, is seeking a Production Associate to monitor GMP compliance and ensure production instructions are strictly followed at its Johor Bahru site.

The role involves updating real-time data in DSP and CKL systems, executing qualification and validation protocols, maintaining equipment, and ensuring safe, efficient downstream operations in a cGMP environment.

Qualifications

• Bachelor in Chemical engineering or related.
• Good in soft skill such as communication and teamwork.
• Good in problem solving and decision making.

Responsibilities

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure production instructions are strictly followed.
• Update real time data entry in DSP, CKL, LS, ECC and other documents.
• Execute equipment qualification and validation protocols.
• Knowledgeable in GMP system, GDP and DI.
• Perform and document operations in accordance with cGMP.
• Maintenance of production equipment in coordination with maintenance department.
• Comply with EHS policies and procedures.
• Responsible for OTIF execution of all activities related to Downstream.

Skills

Communication

Teamwork

Problem solving

Education

Bachelor in Chemical engineering or related

Job description

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Roles and Responsibilities

• To monitor the compliance with the requirements of Good Manufacturing Practice
• To ensure the instructions relating to production operations are strictly followed
• To update the real time data entry in BMR’S,CKL ,LS ,ECC and other documents in DSP
• To execute equipment qualification protocols and validation protocols
• Knowledgeable in GMP system, GDP and DI.
• To perform and document operations in accordance with cGMP
• Maintenance of Production equipment in co-ordination with maintenance department
• To comply with EHS policies and procedures
• Responsible for OTIF execution of all the activities related to Downstream
• Bachelor in Chemical engineering or related
• Good in soft skill such as communication and team work.
• Good in Problem solving and decision making