GMP Production Associate - Biopharma Ops & Compliance

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, 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.