Novoheart Limited

QA Officer (GMP)

Novoheart Limited
Posted on 16-Apr-21

QA Officer (GMP)

Novoheart Limited

Job Highlights

  • HK biotechnology, PIC/S GMP, QA, CAPA, QRM
  • biomedical, life sciences, SOPs related to QA
  • therapeutics, biological & cell products, PQR

Job Description

Job Description:
  • 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.

Additional Information

Career Level
Entry Level
Years of Experience
2 years
Job Type
Full Time, Permanent

Company Overview

Novoheart is a global stem cell biotechnology company with operations in the US, Canada and Hong Kong.  The company is dedicated to engineering bioartificial human heart prototypes using state-of-the-art stem cell and bioengineering approaches. We are seeking highly motivated individuals to join us as one of our professional associates at our established and expanding facility.

Additional Company Information

Industry
Others
Benefits & Others
Life insurance, Medical insurance, Performance bonus, Five-day work week