Production Junior Associate , Associate ,Senior Associate – Drug Substance

Biocon Biologics; Johor Bahru; On-site; MYR 60,000 - 100,000; Full time

Job summary

Biocon Biologics, a subsidiary of Biocon Ltd, is a leading biosimilars company focused on delivering high-quality biologics. This role supports cGMP manufacturing operations, document integrity and audit readiness at the production plant in Malaysia.

The candidate will ensure accurate batch records, adherence to SOPs, and continuous improvement in a regulated environment, with emphasis on training and CAPA effectiveness.

Qualifications

• Bachelor’s degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent.
• 1–6 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.
• Knowledge of cGMP, GDP, Data Integrity, and pharmaceutical manufacturing practices.
• Understanding of ALCOA principles and documentation compliance.
• Strong communication and coordination skills.
• Problem-solving and investigation handling capabilities.
• Ability to work in a regulated manufacturing environment.
• Familiarity with deviations, CAPA, OOS, and OOT management.

Responsibilities

• Gain knowledge and understanding of applicable GxP requirements based on job profile, including cGMP, GDP, Data Integrity, GLP and other relevant trainings.
• Provide guidance and recommendations to ensure compliance with Data Integrity (DI) and Good Documentation Practices (GDP).
• Ensure all documentation is accurate, timely, legible, complete, and permanent in accordance with ALCOA principles.
• Execute production process operations and monitor batch performance as per approved SOPs; ensure cGMP compliance during all activities.
• Execute instructions related to production operations effectively and efficiently.
• Adhere to Environmental Health & Safety (EHS) policies and procedures at all times.
• Update Batch Manufacturing Records (BMRs) and other production documents in real time.
• Ensure proper maintenance and utilization of raw materials as per production requirements.
• Report, evaluate, investigate, and close deviations, CAPA, OOS, and OOT within defined timelines.
• Ensure implementation and effectiveness of CAPA within the plant.
• Coordinate with the Engineering department for timely maintenance of production premises and equipment.
• Communicate and elevate process and facility related issues to higher management in a timely manner
• Prepare, review, and revise SOPs, records, and other required documentation as necessary.
• Implement and maintain GDP practices in accordance with ALCOA principles.
• Conduct employee training programs and ensure all training records are maintained and updated.
• Support and handle internal and external audits, ensuring audit readiness and compliance.

Skills

GxP knowledge

ALCOA principles

cGMP

GDP

Data Integrity

Strong communication

Coordination

Problem-solving

Education

Biotechnology

Chemical Engineering

Bioprocess Engineering

Biochemistry

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

Responsible for executing production operations in compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Data Integrity (DI), and Environmental Health & Safety (EHS) requirements. Ensure accurate documentation, smooth batch execution, compliance monitoring, training coordination, and audit support within the manufacturing plant.

Key Responsibilities:

• Gain knowledge and understanding of applicable GxP requirements based on job profile, including cGMP, GDP, Data Integrity, GLP and other relevant trainings.
• Provide guidance and recommendations to ensure compliance with Data Integrity (DI) and Good Documentation Practices (GDP).
• Ensure all documentation is accurate, timely, legible, complete, and permanent in accordance with ALCOA principles.
• Execute production process operations and monitor batch performance as per approved standard operating procedures (SOPs).Ensure compliance with current Good Manufacturing Practices (cGMP) during all manufacturing activities.
• Execute instructions related to production operations effectively and efficiently.
• Adhere to Environmental Health & Safety (EHS) policies and procedures at all times.
• Update Batch Manufacturing Records (BMRs) and other production documents in real time.
• Ensure proper maintenance and utilization of raw materials as per production requirements.
• Report, evaluate, investigate, and close deviations, CAPA, OOS, and OOT within defined timelines.
• Ensure implementation and effectiveness of Corrective and Preventive Actions (CAPA) within the plant.
• Coordinate with the Engineering department for timely maintenance of production premises and equipment.
• Communicate and elevate process and facility related issues to higher management in a timely manner
• Prepare, review, and revise SOPs, records, and other required documentation as necessary.
• Implement and maintain GDP practices in accordance with ALCOA principles.
• Conduct employee training programs and ensure all training records are maintained and updated.
• Support and handle internal and external audits, ensuring audit readiness and compliance.
• Bachelor’s Degree in Biotechnology, Chemical Engineering, Bioprocess Engineering, Biochemistry or equivalent field.
• 1 - 6 years of hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations
• Knowledge of cGMP, GDP, Data Integrity, and pharmaceutical manufacturing practices
• Understanding of ALCOA principles and documentation compliance
• Strong communication and coordination skills
• Problem-solving and investigation handling capabilities
• Ability to work in a regulated manufacturing environment
• Familiarity with deviations, CAPA, OOS, and OOT management