- 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.
- Raise quality issues to QA Manager and Authorized Person in a timely manner.
- Support qualification / validation documentation and activities.
- Other duties as assigned by the supervisor or management team.
Qualification and requirements:
- A holder of a bachelor’s degree in Life Science discipline such as biotechnology, biomedical, biochemistry and medical laboratory science, with at least 2 years of working experience.
- 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.
To apply, please email your CV and covering letter explaining why you want to work for Novoheart and/or Xellera Therapeutics.