Senior GMP Documentation & Compliance Specialist

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

Job summary

Biocon Biologics seeks a skilled professional to prepare, review and maintain GMP documentation and support cGMP compliance. The role includes CAPA investigations, audits, and documentation control in line with ALCOA++ principles.

The ideal candidate holds a relevant degree and 3–5 years in DRUG SUBSTANCE manufacturing or related operations, contributing to facility expansion and equipment installation activities within a global biopharmaceutical setting.

Qualifications

• Bachelor's degree in chemical engineering, Chemistry, Biochemistry or equivalent field.
• 3-5 years hands-on experience in biopharmaceutical or pharmaceutical Drug Substance manufacturing or related process operations.

Responsibilities

• Prepare, review and maintain GMP documentation including batch Procedures and Equipment Operating Procedures.
• Ensure accuracy, completeness, and compliance of all documentation with applicable GMP requirements.
• Prepare investigation reports and implement corrective and preventive actions (CAPA).
• Support facility expansion projects and equipment installation activities.
• Review qualification protocols and reports to ensure compliance with GMP requirements.
• Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards.
• Follow Environmental Health and Safety (EHS) policies and procedures at all times.
• Support internal and external audits, inspections, and compliance initiatives.
• Update and maintain Batch Manufacturing Records and other GMP documentation in accordance with ALCOA++ principles.
• Adherence to Standard Operating Procedures, Operational Control Procedures.

Education

Bachelor's degree in chemical engineering, Chemistry, Biochemistry or equivalent field

3 - 5 years in biopharmaceutical or pharmaceutical Drug Substance manufacturing

Tools

GMP documentation

Job description

Biocon Biologics seeks a skilled professional to prepare, review and maintain GMP documentation and support cGMP compliance. The role includes CAPA investigations, audits, and documentation control in line with ALCOA++ principles.

The ideal candidate holds a relevant degree and 3–5 years in DRUG SUBSTANCE manufacturing or related operations, contributing to facility expansion and equipment installation activities within a global biopharmaceutical setting.