Deskripsi Pekerjaan
Are you a results-driven professional seeking to advance your career in the life sciences industry? Biocon, a leading global biopharmaceutical company, is currently looking for a dedicated Biopharmaceutical Production Executive – Drug Substance to join our manufacturing team in Gelang Patah, Johor. In this pivotal role, you will be at the forefront of drug substance manufacturing, ensuring that our life-saving therapies are produced with uncompromising quality and efficiency.
As a Production Executive, you will be responsible for supporting key manufacturing operations, ensuring strict compliance with Good Manufacturing Practice (GMP), and driving timely batch execution. We value innovation, precision, and teamwork. If you are passionate about biotechnology and want to contribute to a company that is reshaping the future of healthcare, this is the perfect opportunity for you to showcase your expertise in a world-class facility.
Tanggung Jawab
- Oversee the end-to-end Drug Substance manufacturing process to ensure efficient, safe, and timely batch execution.
- Maintain strict compliance with cGMP regulations, internal SOPs, and quality standards throughout all production activities.
- Prepare, review, and manage batch records, manufacturing logs, and regulatory documentation to ensure accuracy.
- Identify process bottlenecks and lead continuous improvement initiatives (Lean/Six Sigma) to enhance yield and operational efficiency.
- Conduct routine facility inspections, equipment hygiene checks, and environmental monitoring.
- Collaborate closely with Quality Assurance (QA), Quality Control (QC), and Engineering teams to resolve technical issues.
- Train and mentor junior production staff on standard operating procedures and safety protocols.
Kualifikasi
- Bachelor’s degree in Biotechnology, Chemical Engineering, Pharmaceutical Sciences, or a related engineering field.
- Minimum of 3-5 years of experience in Biopharmaceutical manufacturing, specifically in Drug Substance or upstream processing.
- Strong working knowledge of GMP, regulatory guidelines, and audit requirements.
- Excellent documentation skills with the ability to maintain detailed and compliant records.
- Proficient in data analysis and troubleshooting manufacturing equipment and processes.
- Ability to work in a fast-paced, high-pressure environment and adapt to shift work as required.
- Valid Malaysian driver’s license is preferred for local mobility within the industrial zone.