• Act as Head of Quality Control in organizing and monitoring overall activities and coordination in QC department.
• Ensure that all necessary testing and environmental monitoring are carried out and approve or reject results as appropriate.
• Prepare and approve SOPs relating to QC operations and specifications, and ensure their strict implementation.
• Approve and monitor any contract analyses.
• Check the maintenance of QC premises and equipment.
• Ensure that QC equipment qualifications and validations are done.
• Responsible for training of QC personnel.
• Participate in change control, deviation, CAPA, QRM, supplier evaluation, validation, and other quality-related activities.
• Other duties as assigned by management.

Qualification and requirements:

• A holder of a bachelor’s degree in a discipline such as biotechnology, biomedical engineering, medical laboratory science and other similar disciplines with at least 3 years of working experience at managerial or supervisory level in GMP manufacturing or quality control of ATPs; OR
• A holder of a postgraduate degree of science relevant to cell therapy, gene therapy, regenerative medicines or tissue engineering, or other similar sciences with at least 2 years of working experience at managerial or supervisory level in GMP manufacturing or quality control of ATPs; OR
• A holder of a degree of PhD of science relevant to cell therapy, gene therapy, regenerative medicines or tissue engineering, or other related sciences with at least 1 year of working experience at managerial or supervisory level in GMP manufacturing or quality control of ATPs; OR
• A holder of a degree of PhD of science relevant to cell therapy, gene therapy, regenerative medicines or tissue engineering, or other related sciences with at least 2 years of post-doctoral working experience in the processing or quality control of cells, genes and tissue engineered products and with evidence of theoretical and practical training in GMP principles related to ATP manufacturing.
• Preferably with knowledge and/or experience in QC of sterile pharmaceutical products, biological substances and products, active pharmaceutical ingredients, and/or investigational medicinal products.
• Preferably with knowledge and/or experience in conducting sterility test, endotoxin test, mycoplasma test, and tests specific to cell-based products.
• Strong leadership skills with ability to motivate staff members and develop a culture of operational excellence.
• Excellent communication, problem-solving, time management and prioritization skills
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.

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