Deskripsi Pekerjaan
Biocon is a global biotechnology company dedicated to improving the quality of life through innovation. We are currently seeking a dedicated Production Associate to join our Drug Substance manufacturing team in Iskandar Puteri. In this role, you will be instrumental in executing production operations that adhere to the highest standards of Good Manufacturing Practice (cGMP). We value a culture of safety and precision, ensuring strict compliance with Environmental, Health, and Safety (EHS) regulations. As a member of our dynamic team, you will engage in batch monitoring, manage deviations, and maintain comprehensive documentation to guarantee product integrity. We invite qualified candidates to apply and contribute to our mission of affordable healthcare.
Tanggung Jawab
- Execute production operations for Drug Substance batches ensuring strict compliance with cGMP and EHS standards.
- Monitor batch processes in real-time to ensure product quality, yield, and consistency.
- Maintain accurate and up-to-date batch records, deviation reports, and equipment logs.
- Participate in the investigation and resolution of deviations and root cause analysis.
- Coordinate with maintenance and engineering teams to ensure optimal equipment performance.
- Assist in the training and development of junior staff and new operators.
- Adhere to standard operating procedures (SOPs) and safety protocols at all times.
Kualifikasi
- Degree in Pharmacy, Chemical Engineering, Biotechnology, or related Life Sciences field.
- Experience in pharmaceutical manufacturing, specifically in Drug Substance or API production, is preferred.
- Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements.
- Excellent attention to detail and ability to work in a regulated, quality-focused environment.
- Basic computer literacy (SAP, MS Office) and ability to learn new systems quickly.
- Ability to work flexible shifts, including night shifts and weekends, as required.
- Strong communication skills and a collaborative team player attitude.