Technician (carrying the job title of ‘Assistant QA Manager') at The Chinese University of Hong Kong

, Hong Kong, China -

Full Time

Start Date

Immediate

Expiry Date

09 Apr, 26

Salary

0.0

Posted On

09 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, SOP Preparation, Change Control, Deviation Management, Risk Assessment, CAPA, cGMP Compliance, Continuous Improvement, Qualification Protocols, Validation, Interpersonal Skills, Organizational Skills, Aseptic Processing, Cell Therapy, Gene Therapy

Industry

Higher Education

Description

Chinese University Institute of Biotechnology Technician (carrying the job title of ‘Assistant QA Manager’) Are you eager to make a significant impact in the groundbreaking field of cell therapy? We are looking for a highly motivated team player and pioneer who embraces challenges to join our dynamic team where innovation meets dedication. This is an exciting opportunity to be part of a team that is making a difference. If you are ready to take your career to the next level and contribute to life-changing therapeutic advancements, we would love to hear from you. For more information about the Advanced Therapy Products GMP Centre, please visit: https://atp.hkib.org.hk/. As part of the Advanced Therapy Products GMP Centre, the appointee will be at the forefront of quality assurance. Duties include (a) managing QA operations, including SOP preparation, line-clearance, change control, deviation, risk assessment, and CAPA; (b) ensuring compliance with PIC/S and cGMP standards; (c) maintaining and implementing continuous improvements to the quality management system; (d) preparing and reviewing qualification protocols and reports; (e) conducting periodic reviews and validations of critical systems and processes; (f) co-ordinating with the Production and Quality Control Department for the manufacturing of cell-based therapeutic products; and (g) participating in and supporting regulatory inspections. Applicants should have (i) a Bachelor’s degree or above in Biomedical Sciences, Biotechnology, Pharmacy, or related disciplines; (ii) at least 2 years’ GMP experience, with knowledge of HK pharmaceutical GMPs; (iii) strong interpersonal and organisational skills; (iv) a self-motivated and team-oriented work attitude with the ability to work independently; and (v) proficiency in both written and spoken English. Having experience in aseptic processing and inspections, as well as a good understanding of cell and gene therapy, is preferred. Appointment will initially be made on a 2-year contract, renewable subject to good performance and mutual agreement. The University only accepts and considers applications submitted online for the post above via the CUHK career site. For more information and to apply online, please visit http://career.cuhk.edu.hk.

Responsibilities

The appointee will manage QA operations, ensuring compliance with quality standards and maintaining the quality management system. They will also coordinate with production and quality control for the manufacturing of cell-based therapeutic products.