- Assist the QA Manager and Authorized Person in organizing daily operations of QA Department.
- Review of cleanroom / utilities / equipment DQ/IQ/OQ/PQ protocols and reports, and various validation protocols and reports.
- Prepare Product Quality Review and Management Review Reports for review by QA Manager and Authorized Person.
- Organize and assist in preparation of self-inspections and external audits.
- Prepare training materials on GMP and aseptic operation topics.
- Prepare and review SOPs related to QA Department.
- Perform initial assessment of change controls, deviation investigations, OOS, CAPA, quality risk assessments, review of qualification and validation documents and supplier evaluations.
- Raise quality issues to the QA Manager and Authorized Person in a timely manner.
- Other duties as assigned by the supervisors or management team.
Qualification and requirements:
- A holder of a bachelor’s degree in Life Science discipline such as biotechnology, biomedical, biochemistry, chemistry and medical laboratory science, with at least 5 years of working experience.
- At least 1 year of experience in supervisory role in pharmaceutical GMP environment.
- 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.
- Proficiency in English and Chinese, and computer skills.
- Attention to details and a team player with self motivation.
- Excellent communication, problem-solving, time management and prioritization skills.
This position is to be hired under Xellera Therapeutics Limited, which is an affiliated company with Novoheart Limited and holds the GMP facilities for the group. To apply, please email your CV and covering letter explaining why you want to work for Xellera Therapeutics.
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