Biopharma Drug Product Executive

About the role

Join Biocon Malaysia's Manufacturing team and play a key role in supporting drug production operations while ensuring compliance with cGMP, quality, and regulatory requirements. You will be responsible for managing production documentation, driving quality system activities, and collaborating with cross-functional teams to support safe, efficient, and compliant manufacturing operations.

Key responsibilities

• Support day-to-day drug production operations in compliance with cGMP, quality, and safety requirements.
• Manage Quality Management System (QMS) activities, including deviations, change controls, CAPAs, OOS investigations, and associated documentation.
• Prepare, review, and maintain GMP-related documents, including SOPs, batch records, logbooks, protocols, and reports.
• Ensure all manufacturing documentation is completed accurately, thoroughly, and on time in accordance with data integrity requirements.
• Coordinate with Quality Assurance and cross-functional teams to facilitate timely closure of quality and compliance actions.
• Monitor and maintain compliance with regulatory, quality, and company standards across production activities.
• Support internal audits, inspections, and audit readiness initiatives.
• Track and maintain controlled documents, master lists, document registers, and training records.
• Identify and escalate operational, quality, compliance, or safety issues when required.
• Drive continuous improvement initiatives to enhance operational efficiency and compliance.

Requirements

• Bachelor's Degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, Life Sciences, or a related discipline.
• Knowledge of cGMP, quality systems, and pharmaceutical manufacturing processes.
• Good communication and documentation skills.
• Strong attention to detail, problem-solving skills, and ability to work in a cross-functional environment.
• Proficient in Microsoft Office applications.
• Relevant experience in pharmaceutical manufacturing or GMP-regulated environments will be an added advantage.