Drug Substance Production Specialist

Biocon Sdn Bhd; Iskandar Puteri; On-site; MYR 54,000 - 76,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Insurance coverage for you and family

Annual and casual leave

Duty meals provided

In-house gym/sports room

Career advancement opportunities

Job summary

Biocon Sdn Bhd in Malaysia seeks a Production Junior Associate to support drug substance manufacturing in a cGMP environment. You will execute production operations, maintain batch records, ensure data integrity, and assist in audits while coordinating training and CAPA activities.

Ideal candidates have 1–6 years in pharma manufacturing, strong documentation skills, and the ability to work in a regulated setting. Biocon offers competitive benefits and growth opportunities.

Qualifications

• 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.
• 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.
• Good documentation and reporting skills.

Responsibilities

• Execute production operations in compliance with cGMP, GDP, DI and EHS requirements.
• Update BMRs and production documents in real time.
• Provide guidance to ensure Data Integrity and GDP compliance.
• Coordinate with Engineering for maintenance of premises and equipment.
• Support and handle internal and external audits and CAPA implementation.
• Prepare, review and revise SOPs and training records.

Skills

cGMP knowledge

GDP knowledge

Data Integrity

ALCOA

Documentation

Interpersonal skills

Problem-solving

Education

Biotechnology

Chemical Engineering

Bioprocess Engineering

Biochemistry

Job description

Biocon Sdn Bhd in Malaysia seeks a Production Junior Associate to support drug substance manufacturing in a cGMP environment. You will execute production operations, maintain batch records, ensure data integrity, and assist in audits while coordinating training and CAPA activities.

Ideal candidates have 1–6 years in pharma manufacturing, strong documentation skills, and the ability to work in a regulated setting. Biocon offers competitive benefits and growth opportunities.