Job Responsibilities:
Ensure compliance to GMP regulation and SOPs.
Be responsible in the qualification and requalification of the process equipment.
Be responsible for the daily management of equipment, including equipment acceptance, asset registration form and equipment release.
Responsible for equipment life cycle management (from commissioning to qualification and decommissioning).
Participate in the investigation of deviation and variation.
Drafting/maintaining SOPs and relevant process documents.
Support change control and audit.
Any other work assigned by Supervisor.
Qualification
Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.
Minimum of 3 years of hands-on experience in biopharmaceutical manufacturing
Demonstrates a good understanding of cGMP and GDP requirements in a regulated manufacturing environment.
Exhibits a good quality mindset, with awareness of compliance and documentation requirements.
Possesses good technical and operational skills to support routine manufacturing activities.
Demonstrates good communication and coordination skills, enabling effective teamwork and collaboration.
Proficient in basic use of Microsoft Word, PowerPoint, and Excel for documentation and reporting.
Demonstrates basic leadership qualities, with the ability to support team activities when required.
Possesses basic management skills, including task coordination and adherence to operational plans.