• Prepare and review SOPs related to QA Department.
• SOP distribution and withdrawal, and related document control.
• Participate in Pharmaceutical Quality System (PQS) activities including change control, deviation, CAPA and quality risk assessment.
• Assist in preparation and delivery of GMP training.
• Participate in internal audits / self-inspection and external audits.
• Maintain supplier evaluation program.
• Assist in evaluation of hygiene status and aseptic operations.
• Report any conditions (relating to premises, equipment or personnel) that might adversely affect the quality of products and testing results to the Head of QA / Authorized Person.
• Support qualification / validation documentation and activities.
• Other duties as assigned by Head of QA / Authorized Person.

Qualification and requirements:

• A holder of a bachelor’s degree in Life Science discipline such as biotechnology, biochemistry, chemistry and medical laboratory science, with at least 2 years of working experience.
• Proficiency in English and Chinese, and computer skills.
• Knowledge of PIC/S GMP and other quality system / quality assurance principles.
• Preferably with knowledge and/or experience in GMP operations of sterile pharmaceutical products, biological substances or products, or cell-based products.
• Attention to details.
• Excellent communication, problem-solving, time management and prioritization skills.
• Self-motivated and a team player.

To apply, please email your CV and covering letter explaining why you want to work for Novoheart.