GxP Compliance & Downstream Operations Lead

Biocon Sdn Bhd; Johor Bahru; On-site; MYR 180,000 - 230,000; Full time

Job summary

Biocon Sdn Bhd in Malaysia is seeking professionals with a strong background in GMP environments to support GxP training and documentation quality. The role emphasizes understanding cGMP, GDP and data integrity within a biopharma setting and ensuring compliance across production and documentation.

Ideal candidates will have extensive pharma experience, strong analytical skills, and the ability to work in cross-functional manufacturing teams, contributing to training and quality assurance

Qualifications

• Bachelor's or Master's degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or related disciplines with 8+ years of pharma experience.
• Strong knowledge of cGMP, GDP, Data Integrity, QMS, and equipment qualification.
• Good documentation, troubleshooting, and interpersonal skills.

Skills

cGMP knowledge

GDP knowledge

Data Integrity

QMS

Documentation

Interpersonal skills

Education

Biotech/Life Sciences degree (Bachelor/Master)

Job description

Biocon Sdn Bhd in Malaysia is seeking professionals with a strong background in GMP environments to support GxP training and documentation quality. The role emphasizes understanding cGMP, GDP and data integrity within a biopharma setting and ensuring compliance across production and documentation.

Ideal candidates will have extensive pharma experience, strong analytical skills, and the ability to work in cross-functional manufacturing teams, contributing to training and quality assurance