DUTIES & RESPONSIBILITES (Summarizes the job’s purpose or role and why it exists in the organization)
Responsible for qualification/validation of DS&DP system and process.
Create/review/execute qualification/validation policy and procedure.
Create/review/execute protocol, test script, risk assessment, report, and relevant documents of qualification/validation.
Review and approve qualification/validation protocol and report published by supplier.
Support in SOP developing of DS&DP system and process.
Maintain the qualified/validated state of DS&DP system and process during the whole lifecycle.
Responsible for handling Deviation, Change Control, CAPA regarding qualification/validation of DS&DP system and process.
Support GMP audit/inspection regarding qualification/validation of DS&DP system and process.
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/ISPE Guideline.
Familiar with basic statistics knowledge & tools.
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 the qualification and validation management of DS&DP system and process in STD project of Harbour BioMed (HBM).
Work closely with business functions to support the business needs and ensure the GMP compliance.