Taron Solutions Limited Taron Solutions Limited is a contract development and manufacturing company (CDMO) for biopharmaceuticals which provide innovative processes and proprietary know-how for fast and reliable process development and scale-up production that will meet GMP requirements and one-stop...

Taron Solutions Limited

 

Taron Solutions Limited is a contract development and manufacturing company (CDMO) for biopharmaceuticals which provide innovative processes and proprietary know-how for fast and reliable process development and scale-up production that will meet GMP requirements and one-stop solution from early cell development, protein modification, optimization, formulation, to GMP manufacturing.

Senior Quality Assurance Officer / Supervisor

Job level Middle
Work exp Minimum 2 Years
Location
Within Hong Kong
Industry Biotechnology / Chemicals / Testing / Laboratory
Job function Science / Lab / Research > Biotechnology
Published On 03/02/2020
ref. TS-QA001

Summary

Taron Solutions Limited is entering an exciting period to build our global brand servicing pharma and biopharma industries. We are looking for a Quality Assurance Professional at our Hong Kong Headquarters to join our project in developing and setting up the quality system for our sterile manufacturing facility. The individual conducts duties and responsibilities listed below, plus any other tasks as requested by the supervisor.

 

Duties and Responsibilities

  • To prepare validation documents for production equipment.
  • To assist in building the QMS for PIC/S GMP application of sterile biological products.
  • To assist in submission of GMP application package.
  • Responsible for GMP self inspection
  • To coordinate quality issues
  • In charge of risk assessment, deviation management, change control system, CAPA system
  • To responsible for document control
  • To create and maintain the training system
  • To provide initial and continuous training relate to quality
  • To ensure appropriate qualification, validation are done in accordance to PIC/S GMP requirement
  • The review and authorisation of GMP written procedures and other documents, including amendments
  • To create the supplier evaluation system for staring materials and packaging materials
  • Arrange and participate in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement
  • Works well with peers from different disciplines and a good team player to achieve departmental and company goals.
  • Perform any ad hoc works assigned by supervisor.

 

Requirements:

  • Holders of a bachelor's degree or above in relevant science subject, such as Quality Assurance, pharmaceutical science, pharmacy, biomedical science, biotechnology, chemical engineering, etc.
  • With working experience in sterile GMP pharmaceutical Quality Assurance is an advantage.
  • With working experience in advance therapeutic product is a plus.

 

Salary will be based on educational level, discipline, and years of experience. Other benefits based on short-term and long-term incentive performance base (cash and stock options)

Candidates interested in applying for this position can send a cover letter as well as an updated CV with contact information to the following