Associate

Biocon Biologics Limited; Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

Biocon Biologics Limited is hiring for a production support role focusing on GMP compliance and data integrity. You will ensure adherence to cGMP, maintain accurate production records, and support equipment qualification and validation activities.

The role requires a relevant Bachelor's degree and 1–4 years of hands-on experience in biopharmaceutical manufacturing, with annual cGMP training and data documentation duties.

Qualifications

• Bachelor’s degree in biotechnology, Chemical Engineering, or equivalent field.
• 1–4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Mandatory cGMP or GxP training and compliance.

Responsibilities

• Monitor compliance with Good Manufacturing Practice requirements.
• Ensure production operation instructions are strictly followed.
• Update real-time data entry in DSP2 and related documents (BMR, CKL, LS, ECC).
• Execute equipment qualification and validation protocols.
• Perform operations in accordance with cGMP and coordinate with maintenance for equipment upkeep.

Skills

GxP awareness

cGMP knowledge

Documentation

Data integrity

Basic microbiology

Education

Bachelor's degree in biotechnology or Chemical Engineering or equivalent

Tools

DSP2 data systems

GxP documentation tools

Job description

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives, and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.

• 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 DSP2.
• To execute equipment qualification protocols and validation protocols.
• To perform and document operations in accordance with cGMP.
• Maintenance of Production equipment in coordination with maintenance department.
• To comply with EHS policies and procedures.
• Responsible for OTIF execution of all the activities related to Downstream Purification-2.
• Data owner for process equipment used in day-to-day activity.
• To gain knowledge on the subject for an employee based on his/her job profile such as (not limited to) Basics of cGMP, GDP, Data Integrity, GLP, Microbiology, or any other GxP Training, as applicable.
• Employee who are involved in GMP activities should undergo mandatory cGMP Training.
• Frequency of mandatory training is once in a year.
• All employees that involving with GxP environment should undergo a mandatory basic microbiology training.
• To provides information guidance and recommendations to facilitate compliance with DI, GDP in documentation.
• To ensure that all documentation is accurate, timely, legible, complete and permanent (ALCOA principle).
• Bachelor’s degree in biotechnology, Chemical Engineering, or equivalent field.
• 1 - 4 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations

Biocon Biologics is an Equal Opportunity, EEO / Aff employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.