DUTIES & RESPONSIBILITES (Summarizes the job’s purpose or role and why it exists in the organization)
Review and approve manufacturing management documents.
Establish and maintain QA relevant documents regarding manufacturing.
Perform quality oversight on manufacturing system, process and documents, including finished product sampling and AQL inspection.
Oversee Deviation/CAPA/Change Control implementation regarding manufacturing.
Carry out master and executed batch record review. Ensure compliance of batch release process.
Support or as Qualified Person for the batch release.
Establish an adequate manufacturing monitoring process, including the definition of key quality indicators.
Actively contribute to continuous improvement initiatives of manufacturing process.
Other duties as assigned by line manager.
JOB REQUIREMENTS (the minimum skills, knowledge and experience required for the role)
University graduate, major in biology, chemistry, pharmacy, machinery, automation.
Minimum 5 years of experience in the Quality area, biopharma experience is preferred.
Familiar with the pharmaceutical industry regulations, such as NMPA/EMA/FDA GMP/ICH.
Excellent organizational, communication, and interpersonal skills.
Good team player, strong sense of responsibility and good flexibility under certain work pressure.
Good English in listening, speaking, reading and writing.
Good computer and software skills.
SCOPE OF ROLE
Work on manufacturing management regarding GMP Quality in STD project of Harbour BioMed (HBM).
Work closely with business functions to support the business needs and ensure the GMP compliance.