Senior QA Officer

Location: Yuen Long, Hong Kong
Functional area: Yuen Long Project
Employment type: Full-time
Job Type: Contract
Position Summary
 
Incorporates GMP into the quality management system at BOTH project and operation level, to ensure project deliverables complies with relevant GMP requirements, and products manufactured are consistently produced and controlled to the required quality standards and GMP compliance, and appropriate to their intended use and as required by the marketing authorization.
 
Job Duties and Responsibilities
 
In general:
·       Assist the Q.A. Manager to assure GMP compliance by continuously enhancing a proper quality management system (QMS);
·       Assist in the monitoring of all GMP controlled documents are clearly specified in a written form and approves specifications, SOPs and other GMP controlled documents accordingly;
·       Assist in handling deviation/non-conformance, corrective action and preventive action (CAPA), change control and risk management are effectively implemented and complied with cGMP/authority requirement;
·       Support the implementation of the QMS such as product complaints, product returns, product recalls, adverse drug reaction (ADR) reporting, internal and external audits and vendor management;
·       Arrange and perform GMP training, induction training and continual training to the department staff;
·       Support the Q.A. Manager to oversee validation program;
·       Supervise the assigned duties and works of Q.A. Officer;
·       As a team lead of assigned tasks.
 
Specific tasks at project level:
 ·       Support the projects relating to automatic warehouse (AWH) and manufacturing execution system (MES);
 ·       Review and ensure all project deliverables complies with relevant GMP requirements;
 ·      Ensure QA inputs and deliverables align with project schedule and requirements.
 
Job Qualifications and Skills
 
·       A holder of bachelor degree in a relevant science subject, preferably in pharmaceutical science or quality management;
·       Minimum 3 years of relevant working experience in Quality Management System at the local or overseas GMP operations, preferably in Quality Assurance or Compliance aspects;
·       Good knowledge with solid GMP experience of WHO, TGA, ICH or PIC/S;
·       Good analytical, interpersonal and communication skills;
·       Good command of written and spoken English and Chinese; 

 
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