Deputy Manager, GMP & Downstream Bioprocessing

Biocon; Johor Bahru; On-site; MYR 180,000 - 300,000; Full time

Job summary

Biocon Biologics, a leading biopharmaceuticals company, seeks a senior professional with 10+ years in pharma to uphold cGMP/GDP standards across downstream manufacturing. You will ensure data integrity, maintain QA/QMS processes, and drive compliant documentation and training.

The role emphasizes ALCOA documentation, deviation management, and cross-functional collaboration to sustain product quality and regulatory readiness in a GMP environment.

Qualifications

• 10+ years of pharma experience, preferably in biopharmaceutical manufacturing.
• Experience in downstream processing and GMP environments.
• Strong knowledge of cGMP, GDP, Data Integrity, QMS, and equipment qualification.
• Good documentation, troubleshooting, and interpersonal skills.

Responsibilities

• Gain knowledge on basics of cGMP, GDP, Data Integrity, GLP and other GxP training.
• Undergo mandatory cGMP training annually.
• Provide guidance to facilitate compliance with DI and GDP in documentation.
• Ensure ALCOA-compliant documentation.
• Monitor compliance with GMP requirements.
• Ensure production instructions are followed.
• Update real-time data entries in BMRs and related docs.
• Ensure proper storage/production per documentation for quality.
• Report and evaluate deviations; investigate critical ones.
• Maintain PDS-Downstream premises and equipment.
• Maintain training records for PDS-Downstream personnel.
• Comply with EHS policies.

Skills

cGMP knowledge

GDP knowledge

Data Integrity

QMS knowledge

Documentation

Education

Bachelor's or Master's in Biotechnology/Life Sciences

Job description

Biocon Biologics, a leading biopharmaceuticals company, seeks a senior professional with 10+ years in pharma to uphold cGMP/GDP standards across downstream manufacturing. You will ensure data integrity, maintain QA/QMS processes, and drive compliant documentation and training.

The role emphasizes ALCOA documentation, deviation management, and cross-functional collaboration to sustain product quality and regulatory readiness in a GMP environment.