Senior Associate - Dispatch & Solvent Recovery (Drug Substance)

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 is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated pure play biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.

https://www.bioconbiologics.com

Roles and Responsibilities

• 1. Prepare, review and maintain GMP documentation include but not limit to batch Procedures and Equipment Operating Procedures.
• 2. Ensure accuracy, completeness, and compliance of all documentation with applicable GMP requirements.
• 3. Prepare investigation reports and implement appropriate corrective and preventive actions (CAPA).
• 4. Support facility expansion projects and equipment installation activities.
• 5. Review qualification protocols and reports to ensure compliance with GMP requirements.
• 6. Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards.
• 7. Follow Environmental Health and Safety (EHS) policies and procedures at all times.
• 8. Support internal and external audits, inspections, and compliance initiatives.
• 9. Update and maintain Batch Manufacturing Records and other GMP documentation in accordance with ALCOA++ principles.
• 10. Adherence to Standard Operating Procedures, Operational Control Procedures.

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